Critical Care MedicinePub Date : 2024-11-01Epub Date: 2024-09-19DOI: 10.1097/CCM.0000000000006406
Erin F Carlton, Moshiur Rahman, Aline B Maddux, Scott L Weiss, Hallie C Prescott
{"title":"Frequency of and Risk Factors for Increased Healthcare Utilization After Pediatric Sepsis Hospitalization.","authors":"Erin F Carlton, Moshiur Rahman, Aline B Maddux, Scott L Weiss, Hallie C Prescott","doi":"10.1097/CCM.0000000000006406","DOIUrl":"10.1097/CCM.0000000000006406","url":null,"abstract":"<p><strong>Objectives: </strong>To determine the frequency of and risk factors for increased post-sepsis healthcare utilization compared with pre-sepsis healthcare utilization.</p><p><strong>Design: </strong>Retrospective observational cohort study.</p><p><strong>Setting: </strong>Years 2016-2019 MarketScan Commercial and Medicaid Database.</p><p><strong>Patients: </strong>Children (0-18 yr) with sepsis treated in a U.S. hospital.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>We measured the frequency of and risk factors for increased healthcare utilization in the 90 days post- vs. pre-sepsis hospitalization. We defined increased healthcare utilization as an increase of at least 3 days in the 90 days post-hospitalization compared with the 90 days pre-hospitalization based on outpatient, emergency department, and inpatient hospitalization. We identified 2801 patients hospitalized for sepsis, of whom 865 (30.9%) had increased healthcare utilization post-sepsis, with a median (interquartile range [IQR]) of 3 days (1-6 d) total in the 90 days pre-sepsis and 10 days (IQR, 6-21 d) total in the 90 days post-sepsis ( p < 0.001). In multivariable models, the odds of increased healthcare use were higher for children with longer lengths of hospitalization (> 30 d adjusted odds ratio [aOR], 4.35; 95% CI, 2.99-6.32) and children with preexisting complex chronic conditions, specifically renal (aOR, 1.47; 95% CI, 1.02-2.12), hematologic/immunologic (aOR, 1.34; 95% CI, 1.03-1.74), metabolic (aOR, 1.39; 95% CI, 1.08-1.79), and malignancy (aOR, 1.89; 95% CI, 1.38-2.59).</p><p><strong>Conclusions: </strong>In this nationally representative cohort of children who survived sepsis hospitalization in the United States, nearly one in three had increased healthcare utilization in the 90 days after discharge. Children with hospitalizations longer than 30 days and complex chronic conditions were more likely to experience increased healthcare utilization.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"1700-1709"},"PeriodicalIF":7.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Critical Care MedicinePub Date : 2024-11-01Epub Date: 2024-09-19DOI: 10.1097/CCM.0000000000006417
Erica D McKenzie, Julie A Kromm, Theodore Mobach, Kevin Solverson, Joshua Waite, Alejandro A Rabinstein
{"title":"Risk Stratification and Management of Acute Respiratory Failure in Patients With Neuromuscular Disease.","authors":"Erica D McKenzie, Julie A Kromm, Theodore Mobach, Kevin Solverson, Joshua Waite, Alejandro A Rabinstein","doi":"10.1097/CCM.0000000000006417","DOIUrl":"10.1097/CCM.0000000000006417","url":null,"abstract":"<p><strong>Objectives: </strong>Guillain-Barré syndrome (GBS) and myasthenia gravis (MG) are the most common causes of acute neuromuscular respiratory failure resulting in ICU admission. This synthetic narrative review summarizes the evidence for the prediction and management of acute neuromuscular respiratory failure due to GBS and MG.</p><p><strong>Data sources: </strong>We searched PubMed for relevant literature and reviewed bibliographies of included articles for additional relevant studies.</p><p><strong>Study selection: </strong>English-language publications were reviewed.</p><p><strong>Data extraction: </strong>Data regarding study methodology, patient population, evaluation metrics, respiratory interventions, and clinical outcomes were qualitatively assessed.</p><p><strong>Data synthesis: </strong>No single tool has sufficient sensitivity and specificity for the prediction of acute neuromuscular respiratory failure requiring mechanical ventilation. Multimodal assessment, integrating history, examination maneuvers (single breath count, neck flexion strength, bulbar weakness, and paradoxical breathing) and pulmonary function testing are ideal for risk stratification. The Erasmus GBS Respiratory Insufficiency Score is a validated tool useful for GBS. Noninvasive ventilation can be effective in MG but may not be safe in early GBS. Airway management considerations are similar across both conditions, but dysautonomia in GBS requires specific attention. Extubation failure is common in MG, and early tracheostomy may be beneficial for MG. Prolonged ventilatory support is common, and good functional outcomes may occur even when prolonged ventilation is required.</p><p><strong>Conclusions: </strong>Multimodal assessments integrating several bedside indicators of bulbar and respiratory muscle function can aid in evidence-based risk stratification for respiratory failure among those with neuromuscular disease. Serial evaluations may help establish a patient's trajectory and to determine timing of respiratory intervention.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"1781-1789"},"PeriodicalIF":7.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Critical Care MedicinePub Date : 2024-11-01Epub Date: 2024-08-12DOI: 10.1097/CCM.0000000000006390
Francesca Rubulotta, Sahar Bahrami, Dominic C Marshall, Matthieu Komorowski
{"title":"Machine Learning Tools for Acute Respiratory Distress Syndrome Detection and Prediction.","authors":"Francesca Rubulotta, Sahar Bahrami, Dominic C Marshall, Matthieu Komorowski","doi":"10.1097/CCM.0000000000006390","DOIUrl":"10.1097/CCM.0000000000006390","url":null,"abstract":"<p><p>Machine learning (ML) tools for acute respiratory distress syndrome (ARDS) detection and prediction are increasingly used. Therefore, understanding risks and benefits of such algorithms is relevant at the bedside. ARDS is a complex and severe lung condition that can be challenging to define precisely due to its multifactorial nature. It often arises as a response to various underlying medical conditions, such as pneumonia, sepsis, or trauma, leading to widespread inflammation in the lungs. ML has shown promising potential in supporting the recognition of ARDS in ICU patients. By analyzing a variety of clinical data, including vital signs, laboratory results, and imaging findings, ML models can identify patterns and risk factors associated with the development of ARDS. This detection and prediction could be crucial for timely interventions, diagnosis and treatment. In summary, leveraging ML for the early prediction and detection of ARDS in ICU patients holds great potential to enhance patient care, improve outcomes, and contribute to the evolving landscape of precision medicine in critical care settings. This article is a concise definitive review on artificial intelligence and ML tools for the prediction and detection of ARDS in critically ill patients.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"1768-1780"},"PeriodicalIF":7.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Benefits of Early Rehabilitation for Patients With Acute Heart Failure Requiring IV Inotropic Drugs.","authors":"Kensuke Ueno, Hidehiro Kaneko, Kentaro Kamiya, Akira Okada, Masaaki Konishi, Teruhiko Imamura, Yuta Suzuki, Katsuhito Fujiu, Norifumi Takeda, Hiroyuki Morita, Junya Ako, Koichi Node, Hideo Yasunaga, Norihiko Takeda, Issei Komuro","doi":"10.1097/CCM.0000000000006462","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006462","url":null,"abstract":"<p><strong>Objectives: </strong>The benefits of early rehabilitation for patients with acute heart failure (HF) requiring IV inotropic drugs have yet to be determined. We investigated the association between early rehabilitation and short-term clinical outcomes in patients with acute HF requiring IV inotropic drugs.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Setting: </strong>This study used data including more than 90% of patients at a tertiary emergency hospital in Japan.</p><p><strong>Patients: </strong>This study included patients with acute HF who required IV inotropic drugs within 2 days of admission.</p><p><strong>Interventions: </strong>We compared patients who commenced rehabilitation within 2 days of admission (the early rehabilitation group) and those who did not (the control group).</p><p><strong>Measurements and main results: </strong>Propensity score matching was used to compare in-hospital mortality, 30-day all-cause and HF readmissions, length of stay, and Barthel Index (BI) at discharge between patients who received early rehabilitation and those who did not. Totally, 38,302 patients were eligible for inclusion; of these, 5,127 received early rehabilitation and 5,126 pairs were generated by propensity score matching. After propensity score matching, the patients who received early rehabilitation had a lower in-hospital mortality rate than those who did not (9.9% vs. 13.2%; p < 0.001). The relative risk (95% CI) of early rehabilitation for in-hospital mortality was 0.75 (0.67-0.83). Patients undergoing early rehabilitation exhibited a shorter mean length of stay (25.5 vs. 27.1; p < 0.001), lower 30-day all-cause (14.1% vs. 16.4%; p = 0.001) and HF (8.6% vs. 10.4%; p = 0.002) readmissions, and higher BI scores at discharge (68 vs. 67; p = 0.096). Consistent findings were observed across subgroups, including in patients 80 years old or older, those with a body mass index less than 18.5 kg/m2, and those with BI scores less than 60.</p><p><strong>Conclusions: </strong>The early prescription of rehabilitation was associated with favorable short-term outcomes even for patients with acute HF requiring IV inotropic drugs.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544232","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonas Rusnak, Tobias Schupp, Kathrin Weidner, Marinela Ruka, Sascha Egner-Walter, Jan Forner, Alexander Schmitt, Muharrem Akin, Péter Tajti, Kambis Mashayekhi, Mohamed Ayoub, Ibrahim Akin, Michael Behnes
{"title":"Influence of Right and Left Bundle Branch Block in Patients With Cardiogenic Shock and Cardiac Arrest.","authors":"Jonas Rusnak, Tobias Schupp, Kathrin Weidner, Marinela Ruka, Sascha Egner-Walter, Jan Forner, Alexander Schmitt, Muharrem Akin, Péter Tajti, Kambis Mashayekhi, Mohamed Ayoub, Ibrahim Akin, Michael Behnes","doi":"10.1097/CCM.0000000000006459","DOIUrl":"10.1097/CCM.0000000000006459","url":null,"abstract":"<p><strong>Objectives: </strong>The study investigates the prognostic impact of right bundle branch block (RBBB) and left bundle branch block (LBBB) in patients with cardiogenic shock (CS) compared with no bundle branch block (BBB). In patients with heart failure, existence of RBBB and LBBB has influence on prognosis.</p><p><strong>Design: </strong>Prospective registry-study.</p><p><strong>Setting: </strong>ICU of a tertiary academic hospital in Germany.</p><p><strong>Patients: </strong>Adult patients with CS.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>Consecutive patients with CS were included. The prognostic impact of RBBB and LBBB on 30-day all-cause mortality was tested within the entire cohort and in the subgroup of CS patients with cardiac arrest at admission. The final study cohort comprised 248 patients. Patients with RBBB showed the highest 30-day all-cause mortality followed by LBBB and no BBB (72.5% vs. 52.9% vs. 50.0%; log-rank p = 0.015). These findings were consistent even after solely including CS patients with cardiac arrest (90.0% vs. 73.3% vs. 62.2%; log-rank p = 0.008). After adjustment for lactate, norepinephrine, troponin I, Acute Physiology Score, Society of Cardiovascular Angiography & Interventions shock stage, and heart rate in a multivariable Cox regression analysis, RBBB still revealed a negative impact on 30-day all-cause mortality (hazard ratio [HR], 1.807; 95% CI, 1.107-2.947; p = 0.018), whereas LBBB was not associated with 30-day all-cause mortality. In this multivariable Cox regression model lactate (HR, 1.065; 95% CI, 1.018-1.115; p = 0.006), troponin I (HR, 1.003; 95% CI, 1.001-1.005; p = 0.001), and Acute Physiology Score (HR, 1.033; 95% CI, 1.001-1.066; p = 0.041) were as well associated with 30-day all-cause mortality. Finally, no association of RBBB was found with the incidence of liver or severe renal failure.</p><p><strong>Conclusions: </strong>Besides the Acute Physiology Score, lactate, and troponin levels, RBBB was associated with an increased 30-day all-cause mortality in consecutive CS patients with and without cardiac arrest, whereas LBBB showed no prognostic impact.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elena Spinelli, Joaquin Perez, Valentina Chiavieri, Marco Leali, Nadia Mansour, Fabiana Madotto, Lorenzo Rosso, Mauro Panigada, Giacomo Grasselli, Valentina Vaira, Tommaso Mauri
{"title":"Pathophysiological Markers of Acute Respiratory Distress Syndrome Severity Are Correlated With Ventilation-Perfusion Mismatch Measured by Electrical Impedance Tomography.","authors":"Elena Spinelli, Joaquin Perez, Valentina Chiavieri, Marco Leali, Nadia Mansour, Fabiana Madotto, Lorenzo Rosso, Mauro Panigada, Giacomo Grasselli, Valentina Vaira, Tommaso Mauri","doi":"10.1097/CCM.0000000000006458","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006458","url":null,"abstract":"<p><strong>Objectives: </strong>Pulmonary ventilation/perfusion (V/Q) mismatch measured by electrical impedance tomography (EIT) is associated with the outcome of patients with the acute respiratory distress syndrome (ARDS), but the underlying pathophysiological mechanisms have not been fully elucidated. The present study aimed to verify the correlation between relevant pathophysiological markers of ARDS severity and V/Q mismatch.</p><p><strong>Design: </strong>Prospective observational study.</p><p><strong>Setting: </strong>General ICU of a university-affiliated hospital.</p><p><strong>Patients: </strong>Deeply sedated intubated adult patients with ARDS under controlled mechanical ventilation.</p><p><strong>Interventions: </strong>Measures of V/Q mismatch by EIT, respiratory mechanics, gas exchange, lung imaging, and plasma biomarkers.</p><p><strong>Measurements and main results: </strong>Unmatched V/Q units were assessed by EIT as the fraction of ventilated nonperfused plus perfused nonventilated lung units. At the same time, plasma biomarkers with proven prognostic and mechanistic significance for ARDS (carbonic anhydrase 9 [CA9], hypoxia-inducible factor 1 [HIF1], receptor for advanced glycation endproducts [RAGE], angiopoietin 2 [ANG2], gas exchange, respiratory mechanics, and quantitative chest CT scans were measured. Twenty-five intubated ARDS patients were included with median unmatched V/Q units of 37.1% (29.2-49.2%). Unmatched V/Q units were correlated with plasma levels of CA9 (rho = 0.47; p = 0.01), HIF1 (rho = 0.40; p = 0.05), RAGE (rho = 0.46; p = 0.02), and ANG2 (rho = 0.42; p = 0.03). Additionally, unmatched V/Q units correlated with plateau pressure (r = 0.38; p = 0.05) and with the number of quadrants involved on chest radiograph (r = 0.73; p < 0.01). Regional unmatched V/Q units were correlated with the corresponding fraction of poorly aerated lung tissue (r = 0.62; p = 0.01) and of lung tissue weight (rho: 0.51; p = 0.04) measured by CT scan.</p><p><strong>Conclusions: </strong>In ARDS patients, unmatched V/Q units are correlated with pathophysiological markers of lung epithelial and endothelial dysfunction, increased lung stress, and lung edema. Unmatched V/Q units could represent a comprehensive marker of ARDS severity, reflecting the complex organ pathophysiology and reinforcing their prognostic significance.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bram Tilburgs, Koen S Simons, Stijn Corsten, Brigitte Westerhof, Thijs C D Rettig, Esther Ewalds, Marieke Zegers, Mark van den Boogaard
{"title":"Associations Between Physical, Cognitive, and Mental Health Domains of Post-Intensive Care Syndrome and Quality of Life: A Longitudinal Multicenter Cohort Study.","authors":"Bram Tilburgs, Koen S Simons, Stijn Corsten, Brigitte Westerhof, Thijs C D Rettig, Esther Ewalds, Marieke Zegers, Mark van den Boogaard","doi":"10.1097/CCM.0000000000006461","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006461","url":null,"abstract":"<p><strong>Objectives: </strong>To explore associations between the physical, cognitive, and mental post-intensive care syndrome (PICS) health domains with changes in health-related quality of life (HRQoL) following ICU admission.</p><p><strong>Design: </strong>A longitudinal prospective multicenter cohort study.</p><p><strong>Setting/patients: </strong>Patients (n = 4092) from seven Dutch ICUs.</p><p><strong>Interventions: </strong>None.</p><p><strong>Measurements and main results: </strong>At ICU admission, 3 and 12 months post-ICU, patients completed validated questionnaires regarding physical health problems, cognitive health problems, mental health problems, and HRQoL. Composite scores were created for the physical health domain (physical problems and fatigue) and mental health domain (anxiety, depression, and post-traumatic stress disorder). Adjusted multivariable linear regression analyses were performed, including covariables (e.g., patient characteristics, disease severity, pre-ICU HRQoL, etc.) to explore associations between the physical, cognitive, and mental health domains of PICS and changes in HRQoL at 3 and 12 months post-ICU. At 3 months (n = 3368), physical health problems (β = -0.04 [95% CI, -0.06 to 0.02]; p < 0.001), cognitive health problems (β = -0.05 [95% CI, -0.09 to -0.02]; p < 0.001), and mental health problems (β = -0.08 [95% CI, -0.10 to -0.05]; p < 0.001) were negatively associated with changes in HRQoL. Also, at 12 months (n = 2950), physical health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001), cognitive health problems (β = -0.04 [95% CI, -0.08 to -0.01]; p < 0.015), and mental health problems (β = -0.06 [95% CI, -0.08 to -0.03]; p < 0.001) were negatively associated with changes in HRQoL.</p><p><strong>Conclusions: </strong>PICS symptoms in the physical, cognitive, and mental domains are all negatively associated with changes in HRQoL at 3 and 12 months post-ICU. At 3 months, PICS symptoms in the mental domain seem to have the largest negative associations. At 12 months, the associations of PICS in the mental and physical domains are the same. This implies that daily ICU care and follow-up care should focus on preventing and mitigating health problems across all three PICS domains to prevent a decrease in HRQoL.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496528","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Faraaz Ali Shah, Victor B Talisa, Chung-Chou H Chang, Sofia Triantafyllou, Lu Tang, Florian B Mayr, Alisa M Higgins, Sandra L Peake, Paul Mouncey, David A Harrison, Kimberley M DeMerle, Jason N Kennedy, Gregory F Cooper, Rinaldo Bellomo, Kathy Rowan, Donald M Yealy, Christopher W Seymour, Derek C Angus, Sachin P Yende
{"title":"Heterogeneity in the Effect of Early Goal-Directed Therapy for Septic Shock: A Secondary Analysis of Two Multicenter International Trials.","authors":"Faraaz Ali Shah, Victor B Talisa, Chung-Chou H Chang, Sofia Triantafyllou, Lu Tang, Florian B Mayr, Alisa M Higgins, Sandra L Peake, Paul Mouncey, David A Harrison, Kimberley M DeMerle, Jason N Kennedy, Gregory F Cooper, Rinaldo Bellomo, Kathy Rowan, Donald M Yealy, Christopher W Seymour, Derek C Angus, Sachin P Yende","doi":"10.1097/CCM.0000000000006463","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006463","url":null,"abstract":"<p><strong>Objectives: </strong>The optimal approach for resuscitation in septic shock remains unclear despite multiple randomized controlled trials (RCTs). Our objective was to investigate whether previously uncharacterized variation across individuals in their response to resuscitation strategies may contribute to conflicting average treatment effects in prior RCTs.</p><p><strong>Design: </strong>We randomly split study sites from the Australian Resuscitation of Sepsis Evaluation (ARISE) and Protocolized Care for Early Septic Shock (ProCESS) trials into derivation and validation cohorts. We trained machine learning models to predict individual absolute risk differences (iARDs) in 90-day mortality in derivation cohorts and tested for heterogeneity of treatment effect (HTE) in validation cohorts and swapped these cohorts in sensitivity analyses. We fit the best-performing model in a combined dataset to explore roles of patient characteristics and individual components of early goal-directed therapy (EGDT) to determine treatment responses.</p><p><strong>Setting: </strong>Eighty-one sites in Australia, New Zealand, Hong Kong, Finland, Republic of Ireland, and the United States.</p><p><strong>Patients: </strong>Adult patients presenting to the emergency department with severe sepsis or septic shock.</p><p><strong>Interventions: </strong>EGDT vs. usual care.</p><p><strong>Measurements and main results: </strong>A local-linear random forest model performed best in predicting iARDs. In the validation cohort, HTE was confirmed, evidenced by an interaction between iARD prediction and treatment (p < 0.001). When patients were grouped based on predicted iARDs, treatment response increased from the lowest to the highest quintiles (absolute risk difference [95% CI], -8% [-19% to 4%] and relative risk reduction, 1.34 [0.89-2.01] in quintile 1 suggesting harm from EGDT, and 12% [1-23%] and 0.64 [0.42-0.96] in quintile 5 suggesting benefit). Sensitivity analyses showed similar findings. Pre-intervention albumin contributed the most to HTE. Analyses of individual EGDT components were inconclusive.</p><p><strong>Conclusions: </strong>Treatment response to EGDT varied across patients in two multicenter RCTs with large benefits for some patients while others were harmed. Patient characteristics, including albumin, were most important in identifying HTE.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Doctors as Device Manufacturers? Regulation of Clinician-Generated Innovation in the ICU.","authors":"David A Simon, Michael J Young","doi":"10.1097/CCM.0000000000006296","DOIUrl":"https://doi.org/10.1097/CCM.0000000000006296","url":null,"abstract":"<p><p>Critical care physicians are rich sources of innovation, developing new diagnostic, prognostic, and treatment tools they deploy in clinical practice, including novel software-based tools. Many of these tools are validated and promise to actively help patients, but physicians may be unlikely to distribute, implement, or share them with other centers noncommercially because of unsettled ethical, regulatory, or medicolegal concerns. This Viewpoint explores the potential barriers and risks critical care physicians face in disseminating device-related innovations for noncommercial purposes and proposes a framework for risk-based evaluation to foster clear pathways to safeguard equitable patient access and responsible implementation of clinician-generated technological innovations in critical care.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michael R Pinsky, Hernando Gomez, Anthony Wertz, Jim Leonard, Artur Dubrawski, Ronald Poropatich
{"title":"Evaluation of a Physiologic-Driven Closed-Loop Resuscitation Algorithm in an Animal Model of Hemorrhagic Shock.","authors":"Michael R Pinsky, Hernando Gomez, Anthony Wertz, Jim Leonard, Artur Dubrawski, Ronald Poropatich","doi":"10.1097/CCM.0000000000006297","DOIUrl":"10.1097/CCM.0000000000006297","url":null,"abstract":"<p><strong>Objectives: </strong>Appropriate resuscitation from hemorrhagic shock is critical to restore tissue perfusion and to avoid over-resuscitation. The objective of this study was to test the ability of a closed-loop diagnosis and resuscitation algorithm called resuscitation from shock using functional hemodynamic monitoring using invasive monitoring (ReFit1) and minimally invasive monitoring (ReFit2) to identify, treat, and stabilize a porcine model of severe hemorrhagic shock.</p><p><strong>Design: </strong>We created a ReFit algorithm using dynamic hemodynamic parameters of pulse pressure variation (PPV), stroke volume variation (SVV), dynamic arterial elastance (Eadyn = PPV/SVV), driven by mean arterial pressure (MAP), mixed venous oxygen saturation, and heart rate targets to define the need for fluids, vasopressors, and inotropes.</p><p><strong>Setting: </strong>University-based animal laboratory.</p><p><strong>Subjects: </strong>Twenty-seven female pigs.</p><p><strong>Interventions: </strong>Anesthetized, intubated, and ventilated (8 mL/kg) pigs were bled at 10 mL/min until a MAP of less than 40 mm Hg, held for 30 minutes, then resuscitated. The ReFit algorithm used the above dynamic parameters to drive computer-controlled infusion pumps to deliver blood, lactated Ringer's solution, norepinephrine, and in ReFit1 dobutamine. In four animals, after initial resuscitation from hemorrhagic shock, the ability of the ReFit1 algorithm to treat acute air embolism-induced pulmonary hypertension and right heart failure was also tested.</p><p><strong>Main results: </strong>In 10 ReFit1 and 17 ReFit2 animals, the time to stabilization from shock was not dissimilar to open controlled resuscitation performed by an expert physician (52 ± 12, 50 ± 13, and 60 ± 15 min, respectively) with similar amounts of fluids and norepinephrine needed. In four ReFit1 animals after initial stabilization, the algorithm successfully resuscitated the animals after inducing an acute air embolism right heart failure, with all animals recovering stability within 30 minutes.</p><p><strong>Conclusions: </strong>Our physiologically based functional hemodynamic monitoring-centered closed-loop resuscitation system can effectively diagnose and treat cardiovascular shock due to hemorrhage and air embolism.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":""},"PeriodicalIF":7.7,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}