Journal of Anesthesia, Analgesia and Critical Care (Online)最新文献

{"title":"Continuous vs intermittent Non-Invasive blood pressure MONitoring in preventing postoperative organ failure (niMON): study protocol for an open-label, multicenter randomized trial.","authors":"Alberto Noto, Athanasios Chalkias, Fabiana Madotto, Lorenzo Ball, Elena Giovanna Bignami, Maurizio Cecconi, Fabio Guarracino, Antonio Messina, Andrea Morelli, Pietro Princi, Filippo Sanfilippo, Sabino Scolletta, Luigi Tritapepe, Andrea Cortegiani","doi":"10.1186/s44158-024-00142-w","DOIUrl":"10.1186/s44158-024-00142-w","url":null,"abstract":"<p><strong>Background: </strong>Blood pressure has become one of the most important vital signs to monitor in the perioperative setting. Recently, the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care (SIAARTI) recommended, with low level of evidence, continuous monitoring of blood pressure during the intraoperative period. Continuous monitoring allows for early detection of hypotension, which may potentially lead to a timely treatment. Whether the ability to detect more hypotension events by continuous noninvasive blood pressure (C-NiBP) monitoring can improve patient outcomes is still unclear. Here, we report the rationale, study design, and statistical analysis plan of the niMON trial, which aims to evaluate the effect of intraoperative C-NiBP compared with intermittent (I-NiBP) monitoring on postoperative myocardial and renal injury.</p><p><strong>Methods: </strong>The niMon trial is an investigator-initiated, multicenter, international, open-label, parallel-group, randomized clinical trial. Eligible patients will be randomized in a 1:1 ratio to receive C-NiBP or I-NiBP as an intraoperative monitoring strategy. The proportion of patients who develop myocardial injury in the first postoperative week is the primary outcome; the secondary outcomes are the proportions of patients who develop postoperative AKI, in-hospital mortality rate, and 30 and 90 postoperative days events. A sample size of 1265 patients will provide a power of 80% to detect a 4% absolute reduction in the rate of the primary outcome.</p><p><strong>Conclusions: </strong>The niMON data will provide evidence to guide the choice of the most appropriate intraoperative blood pressure monitoring strategy.</p><p><strong>Clinical trial registration: </strong>Clinical Trial Registration: NCT05496322, registered on the 5^th of August 2023.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"7"},"PeriodicalIF":0.0,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10845743/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139699015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of seizure duration and utility of using SedLine^® EEG tracing in veterans undergoing electroconvulsive therapy: a retrospective analysis.","authors":"Houman Amirfarzan, Kaitlin Jane Cassidy, Mehrak Moaddab, Ma Demin, Roman Schumann, Bradford Lewis","doi":"10.1186/s44158-024-00143-9","DOIUrl":"10.1186/s44158-024-00143-9","url":null,"abstract":"<p><strong>Background: </strong>Electroconvulsive therapy (ECT) endures as a definitive treatment for refractory depression and catatonia and is also considered an effective treatment for a number of other severe psychiatric disorders (Lisanby, N Engl J Med 357:1939-1945, 2007)(Weiner and Prudic, Biol Psychiatry 73:105-106, 2013). GA is an essential component of the ECT procedure for various reasons (Lee, Jenkins and Sparkle, Life 11, 2021). Monitoring anesthetic effects on the brain is desirable as anesthetic agents affect seizure duration and recovery (Rasulo, Hopkins, Lobo, et al,  Neurocrit Care 38:296-311, 2023) (Jones , Nittur , Fleming and Applegate,  BMC Anesthesiol 21:105, 2021) (Soehle , Kayser , Ellerkmann and Schlaepfer,  BJA 112:695-702, 2013). Perioperative anesthetic effects on consciousness can be assessed with brain function monitoring using raw electroencephalogram (EEG) traces and processed EEG indices.</p><p><strong>Objective: </strong>We examined the usefulness and utility of the SedLine^® anesthetic effect monitor during ECT procedures. We hypothesized that the seizure duration as measured by the EEG tracing of the ECT machine is equivalent to the duration assessed by the SedLine^® EEG tracing. A secondary objective was to describe the SedLine^® patient state indices (PSI) at different phases of treatment.</p><p><strong>Methods: </strong>Following IRB approval, we analyzed the data of the electronic medical records of 45 ECT treatments of 23 patients in an urban VA medical center between July 01, 2021, and March 30, 2022. We compared the seizure duration in minutes and seconds as measured either by the ECT machine EEG tracing or the SedLine^® EEG tracing. We then collected SedLine^® processed EEG indices at four different stages during the treatment. Appropriate comparative and observational statistical analyses were applied.</p><p><strong>Results: </strong>There was no significant difference in measured seizure duration between the two methods examined (p < 0.05). We observed a lag of the SedLine PSI value at the time before stimulus delivery and limited PSI utility during the course of ECT.</p><p><strong>Conclusion: </strong>The SedLine^® EEG tracing can be an alternative to the machine EEG tracing for the determination of seizure duration. The SedLine^® processed EEG indices are not consistently useful before and after ECT delivery. Anesthetic effect monitoring during ECT is feasible.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"8"},"PeriodicalIF":0.0,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10845389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139699014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cryoglobulinemia: the \"cold\" problem in cardiac surgery, a single-center experience and a literature review.","authors":"Pasquale Raimondo, Gianmarco Intini, Gianfranco Lauletta, Valentina Teora, Sergio Domenico Lenoci, Giovanni Rubino, Maria Arcangela Villani, Agnese Armenise, Antonia Stripoli, Giuseppe Colantuono, Nicola Di Bari, Giuseppe Fiore, Gianluca Paternoster, Salvatore Grasso","doi":"10.1186/s44158-024-00141-x","DOIUrl":"10.1186/s44158-024-00141-x","url":null,"abstract":"<p><p>Cardiac surgery with cardiopulmonary bypass (CBP) is essential for different cardiac procedures in order to perform surgery with a clear sight field.To safely perform surgery with CPB and preserve brain, kidney, and patient tissue from ischemic damage, cold cardioplegia, and mild to deep hypothermia are induced during the operation.Cryoglobulinemia is a hematological/infective-related disease (in certain cases idiopathic) in which temperature-dependent antibodies tend to aggregate and form emboli in the vascular system causing tissue damage if exposed to low temperature.The patient with cryoglobulinemia (known and unknown) can be at risk of a major ischemic event during CPB and induced hypothermia.This article's aim is to evaluate the present scientific literature in order to understand how, in years, the therapeutic or preventive approach, is evolving, and to analyze and make improvements to the management of a cryoglobulinemic patient who must undergo elective or emergency cardiac surgery.In the last part of our article, we expose our single-center experience during a 32-month-long period of survey.In all cases, our medical team (anesthesiologists, perfusionists, and cardiac surgeons) opted for a normothermic cardiopulmonary bypass to lower the risk of cryoglobulin-associated complications.In our experience, along with therapeutic intervention to lower the cryoglobulin titer, normothermic management of cardiopulmonary bypass is as safe as hypothermic management.Notwithstanding our results, further studies with a larger population are needed to confirm this perioperative management in a cardiac surgery setting.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"6"},"PeriodicalIF":0.0,"publicationDate":"2024-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10811818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139565438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bridging knowledge gaps: a bibliometric analysis of non-invasive ventilation in palliative care studies.","authors":"Marco Cascella, Federica Monaco, Alessandro Vittori, Mostafa Elshazly, Annalisa Carlucci, Ornella Piazza","doi":"10.1186/s44158-024-00140-y","DOIUrl":"10.1186/s44158-024-00140-y","url":null,"abstract":"<p><strong>Background: </strong>Despite being a useful strategy for providing respiratory support to patients with advanced or terminal illnesses, non-invasive ventilation (NIV) requires in-depth investigation in several key aspects.</p><p><strong>Objectives: </strong>This bibliometric analysis seeks to comprehensively examine the existing research on the subject. Its goal is to uncover valuable insights that can inform the prediction trajectory of studies, guide the implementation of corrective measures, and contribute to the improvement of research networks.</p><p><strong>Methods: </strong>A comprehensive review of literature on NIV in the context of palliative care was conducted using the Web of Science core collection online database. The search utilized the key terms \"non-invasive ventilation\" and \"palliative care\" to identify the most relevant articles. All data were gathered on November 7, 2023. Relevant information from documents meeting the specified criteria was extracted, and Journal Citation Reports™ 2022 (Clarivate Analytics) served as the data source. The analysis employed literature analysis and knowledge visualization tools, specifically CiteScope (version 6.2.R4) and VOSviewer (version 1.6.20).</p><p><strong>Results: </strong>A dataset with bibliometric findings from 192 items was analyzed. We found a consistent upward of the scientific output trend over time. Guidelines on amyotrophic lateral sclerosis management received the highest number of citations. Most documents were published in top-ranked journals. Less than one-third of the documents pertain to clinical studies, especially retrospective analyses (25%). Key topics such as \"decision making\", and \"communication\" were less addressed.</p><p><strong>Conclusions: </strong>Given the substantial clinical implications, further high-quality studies on this subject are recommended. Encouraging international collaborations is needed. Despite the growing volume of documents in the field, this bibliometric analysis indicates a decline in collaborative networks.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"5"},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10809455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139547624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Update on vitamin D role in severe infections and sepsis.","authors":"Salvatore Lucio Cutuli, Elena Sancho Ferrando, Fabiola Cammarota, Emanuele Franchini, Alessandro Caroli, Gianmarco Lombardi, Eloisa Sofia Tanzarella, Domenico Luca Grieco, Massimo Antonelli, Gennaro De Pascale","doi":"10.1186/s44158-024-00139-5","DOIUrl":"10.1186/s44158-024-00139-5","url":null,"abstract":"<p><p>Severe infections frequently require admission to the intensive care unit and cause life-threatening complications in critically ill patients. In this setting, severe infections are acknowledged as prerequisites for the development of sepsis, whose pathophysiology implies a dysregulated host response to pathogens, leading to disability and mortality worldwide.Vitamin D is a secosteroid hormone that plays a pivotal role to maintain immune system homeostasis, which is of paramount importance to resolve infection and modulate the burden of sepsis. Specifically, vitamin D deficiency has been widely reported in critically ill patients and represents a risk factor for the development of severe infections, sepsis and worse clinical outcomes. Several studies have demonstrated the feasibility, safety and effectiveness of vitamin D supplementation strategies to improve vitamin D body content, but conflictual results support its benefit in general populations of critically ill patients. In contrast, small randomised clinical trials reported that vitamin D supplementation may improve host-defence to pathogen invasion via the production of cathelicidin and specific cytokines. Nonetheless, no large scale investigations have been designed to specifically assess the impact of vitamin D supplementation on the outcome of critically ill septic patients admitted to the intensive care unit.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"4"},"PeriodicalIF":0.0,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10804708/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139541599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analgesic efficacy and safety of erector spinae versus serratus anterior plane block in thoracic surgery: a systematic review and meta-analysis of randomized controlled trials.","authors":"Qurat Ul Ain Muhammad, Muhammad Ahmad Sohail, Noor Mahal Azam, Hafiza Hifza Bashir, Hira Islam, Rana Ijaz, Sakina Aquil, Tehreem Mansoor, Bishal Dhakal, Tehniat Fatima, Javeria Noor, Alina Sami Khan, Arham Iqbal, Mahima Khatri, Satesh Kumar","doi":"10.1186/s44158-023-00138-y","DOIUrl":"10.1186/s44158-023-00138-y","url":null,"abstract":"<p><strong>Background: </strong>Erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) are regional anesthesia techniques that have shown favorable results in pain management following thoracic surgeries; however, their relative superiority is unclear. This review (PROSPERO: CRD42023443018) aims to compare the analgesic efficacy of ESPB and SAPB in patients undergoing thoracic surgeries through the pooled analysis of co-primary outcomes: postoperative oral-morphine-equivalent (mg) consumption in 24 h and pain scores (static) at 24 h.</p><p><strong>Methods: </strong>A literature search was conducted across PubMed, Cochrane Library, and Google Scholar to identify randomized controlled trials (RCTs) from inception to May 2023, comparing ESPB and SAPB in thoracic surgeries. Statistical pooling was done using Review Manager 5.4.1. Bias assessment employed the Cochrane Collaboration Risk-of-Bias 2.0 tool. The strength of evidence was assessed using the guidelines from the GRADE working group.</p><p><strong>Results: </strong>Nine RCTs (485 patients) were included in the study. Postoperative pain scores (static) at 24 h (mean difference (MD) =  - 0.31 [- 0.57, 0.05], p = 0.02) and postoperative oral-morphine-equivalent (mg) consumption in 24 h (MD =  - 19.73 [- 25.65, - 13.80], p < 0.00001) were significantly lower in the ESBP group. However, the MDs did not exceed the set threshold for clinical importance. No significant differences were observed in the opioid-related adverse effects and block-related complications.</p><p><strong>Conclusion: </strong>Our statistically significant results imply that ESPB has superior analgesic efficacy compared to SAPB; however, this difference is clinically unimportant. The safety profile of the two blocks is comparable; hence, current evidence cannot define the relative superiority of one block over the other. Our findings warrant further research with standardized methodologies and a longer duration of analgesic efficacy assessment to yield robust evidence for better clinical applications.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"3"},"PeriodicalIF":0.0,"publicationDate":"2024-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10785351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139433292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The ESICM's digital revolution: Academy Critical Care Education (ACE) courses.","authors":"Mo Al-Haddad, Joana Berger-Estilita, Nathan D Nielsen","doi":"10.1186/s44158-023-00128-0","DOIUrl":"10.1186/s44158-023-00128-0","url":null,"abstract":"","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"2"},"PeriodicalIF":0.0,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10777595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139418757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intensive care following in-hospital cardiac arrest / periarrest calls-experience from one Scottish hospital.","authors":"Andrew R McCallum, Richard Cowan, Kevin D Rooney, Paul C McConnell","doi":"10.1186/s44158-023-00136-0","DOIUrl":"10.1186/s44158-023-00136-0","url":null,"abstract":"<p><strong>Background: </strong>In-hospital cardiac arrest/periarrest is a recognised trigger for consideration of admission to the intensive care unit (ICU). We aimed to investigate the rates of ICU admission following in-hospital cardiac arrest/periarrest, evaluate the outcomes of such patients and assess whether anticipatory care planning had taken place prior to the adult resuscitation team being called.</p><p><strong>Methods: </strong>Analysis of all referrals to the ICU page-holder within our district general hospital is between 1st November 2018 and 31st May 2019. From this, the frequency of adult resuscitation team calls was determined. Case notes were then reviewed to determine details of the events, patient outcomes and the use of anticipatory care planning tools on wards.</p><p><strong>Results: </strong>Of the 506 referrals to the ICU page-holder, 141 (27.9%) were adult resuscitation team calls (114 periarrests and 27 cardiac arrests). Twelve patients were excluded due to health records being unavailable. Admission rates to ICU were low - 17.4% for cardiac arrests (4/23 patients), 5.7% (6/106) following periarrest. The primary reason for not admitting to ICU was patients being \"too well\" at the time of review (78/129 - 60.5%). Prior to adult resuscitation team call, treatment escalation plans had been completed in 27.9% (36/129) with Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) forms present in 15.5% of cases (20/129). Four cardiac arrest calls were made in the presence of a valid DNACPR form, frequently due to a lack of awareness of the patient's resuscitation status.</p><p><strong>Conclusions: </strong>This study highlights the significant workload for the ICU page-holder brought about by adult resuscitation team calls. There is a low admission rate from these calls, and, at the time of resuscitation team call, anticipatory planning is frequently either incomplete or poorly communicated. Addressing these issues requires a collaborative approach between ICU and non-ICU physicians and highlights the need for larger studies to develop scoring systems to aid objective admission decision-making.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"4 1","pages":"1"},"PeriodicalIF":0.0,"publicationDate":"2024-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10763421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139089629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining gender bias in regional anesthesia academic publishing: a 50-year bibliometric analysis.","authors":"Sindi Mustaj, Alessandro De Cassai, Gaya Spolverato, Tommaso Pettenuzzo, Annalisa Boscolo, Paolo Navalesi, Marina Munari","doi":"10.1186/s44158-023-00137-z","DOIUrl":"10.1186/s44158-023-00137-z","url":null,"abstract":"<p><strong>Background: </strong>The connection between academic career advancement and publishing research articles is important, as it can impact promotion and compensation decisions. Gender bias in academic publishing is a known issue, with studies showing low numbers in key roles in female representation. This article aims to analyze the ratio of women to men as first and last authors in the Regional Anesthesia & Pain Medicine (RAPM) journal and explore other factors such as the mentorship effect and representation in regional anesthesia associations.</p><p><strong>Main body: </strong>We examined the RAPM articles from 1976 to 2023 evaluating the gender of first and last authors. We analyzed the trend over the years and also analyze the subset of original articles. A further analysis was conducted to analyze the relationship between the first and last author's gender. Additionally, regional anesthesia societies were contacted to gather data on the gender of their members. We included 5650 articles; most of them were first authored by men (72.9-87.7%). There was a positive trend over time for female first authorship but not for last authorship. The analysis also revealed a mentorship effect in recent years for both overall articles and the subgroup of original articles. The representation of women within regional anesthesia societies contrasted with the representation of women as last authors in original articles.</p><p><strong>Conclusions: </strong>Our findings raise important questions about gender bias in academic publishing highlighting the need for increased representation and opportunities for women in the field of regional anesthesia.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"3 1","pages":"51"},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10702064/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138500375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High versus standard blood pressure target in hypertensive high-risk patients undergoing elective major abdominal surgery: a study protocol for the HISTAP randomized clinical trial.","authors":"Antonio Messina, Andrea Cortegiani, Stefano Romagnoli, Giovanni Sotgiu, Federico Piccioni, Katia Donadello, Massimo Girardis, Alberto Noto, Salvatore Maurizio Maggiore, Massimo Antonelli, Maurizio Cecconi","doi":"10.1186/s44158-023-00133-3","DOIUrl":"10.1186/s44158-023-00133-3","url":null,"abstract":"<p><strong>Background: </strong>The intraoperative period is often characterized by hemodynamic instability, and intraoperative hypotension is a common complication. The optimal mean arterial pressure (MAP) target in hypertensive patients is still not clear. We hereby describe the protocol and detailed statistical analysis plan for the high versus standard blood pressure target in hypertensive high-risk patients undergoing elective major abdominal surgery: the HISTAP randomized clinical trial. The HISTAP trial aims at addressing whether the use of a higher intraoperative MAP target in high-risk hypertensive surgical patients scheduled for elective abdominal surgery would improve postoperative outcomes, as compared to the standard and recommended perioperative MAP, by using a composite outcome including a 30-day mortality from surgical intervention and at least one major organ dysfunction or new onset of sepsis and septic shock occurring 7 days after surgery.</p><p><strong>Methods: </strong>The HISTAP trial is an investigator-initiated, pragmatic, parallel-grouped, randomized, stratified, analyst-blinded trial with adequate allocation sequence generation, and allocation concealment. We will allocate 636 patients to a MAP target ≥ 80 mmHg (treatment group) or to a MAP target ≥65 mmHg (control group). The primary outcome is a composite outcome including a 30-day mortality from the operation and major organ complications. Secondary outcomes are mortality at 30 days, intensive care unit (ICU) length of stay, ICU readmission, Sequential Organ Failure Assessment (SOFA) scores recorded up to postoperative day 7, overall intraoperative fluid balance, vasopressors use, and the need for reoperation. An unadjusted χ² test will be used for the primary outcome analysis. A Cox proportional hazards model will be used to adjust the association between the primary outcome and baseline covariates.</p><p><strong>Conclusions: </strong>The HISTAP trial results will provide important evidence to guide clinicians' choice regarding the intraoperative MAP target in high-risk hypertensive patients scheduled for elective abdominal surgery.</p>","PeriodicalId":73597,"journal":{"name":"Journal of Anesthesia, Analgesia and Critical Care (Online)","volume":"3 1","pages":"50"},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10691117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138471335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}