Contemporary clinical trials最新文献

{"title":"Corrigendum to “Improving communication about goals of care for hospitalized patients with serious illness: Study protocol for two complementary randomized trials”[Contemporary Clinical Trials 2022;120:106879].","authors":"J. Randall Curtis , Robert Y. Lee , Lyndia C. Brumback , Erin K. Kross , Lois Downey , Janaki Torrence , Joanna Heywood , Nicole LeDuc , Kasey Mallon Andrews , Jennifer Im , Bryan J. Weiner , Nita Khandelwal , Nauzley C. Abedini , Ruth A. Engelberg","doi":"10.1016/j.cct.2025.107944","DOIUrl":"10.1016/j.cct.2025.107944","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107944"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143941642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness of a psychological intervention targeting bereaved caregivers of cancer patients: Study protocol for the EMPOWER-Cancer-grief RCT.","authors":"Loukas Christodoulou, Panagiotis Parpottas, Paris Vogazianos, Holly G Prigerson, Wendy Lichtenthal, Eleni Petkari","doi":"10.1016/j.cct.2025.107949","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107949","url":null,"abstract":"<p><strong>Background: </strong>Informal caregivers (e.g., family members) of cancer patients experience significant demands in time, energy and mental resources. While several interventions target cancer caregivers, most focus on distress, overlooking positive outcomes (e.g. resilience and post-traumatic growth). This study aims to test the feasibility, acceptability and effectiveness of an adapted version of the EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) intervention for protecting Cypriot bereaved cancer caregivers against distress and promoting positive outcomes.</p><p><strong>Methods: </strong>The study will follow an open trial and a posterior Randomized Controlled Trial (RCT) design whereby study participants will be randomized 1:1 to either the EMPOWER intervention or the control group arms. Eligible participants will be adult caregivers who experienced a cancer-related loss within the last 18 months and are at risk of prolonged grief disorder (PGD) (i.e., have high scores on the PG-13-R and TRIG). EMPOWER is a blended intervention combining evidence-based cognitive-behavioural approaches, psychoeducation, acceptance-based principles and meaning-centred grief therapy techniques. The adapted intervention (EMPOWER-Cancer-Grief) will consist of individual weekly face-to-face sessions delivered over a six-week period. Control group participants will attend a 1.5-h psycho-educational session. Outcomes will include depression and anxiety symptoms, PGD risk, resilience, post-traumatic growth and experiential avoidance. Data will be collected at baseline, post-treatment and one- and three-month's follow-ups post intervention.</p><p><strong>Discussion: </strong>Findings will provide insight into the intervention effectiveness for decreasing distress and increasing positive outcomes in cancer caregivers, and its feasibility and acceptability with Cypriot sample.</p><p><strong>Trial registration: </strong>ISRCTN12141154.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107949"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Coenrollment in a critical care trial: Characteristics and consequences.","authors":"France Clarke, Lori Hand, Adam Deane, Nicole Zytaruk, Miranda Hardie, Yaseen Arabi, Abdulrahman Al-Fares, Diane Heels-Ansdell, William Dechert, Marlies Ostermann, Irene Watpool, Tina Millen, John Muscedere, Shane English, Gordon Boyd, Stephanie Sibley, Leah Peck, Glenn Eastwood, Erick Duan, Mark Soth, Andreas Freitag, Gloria Vazquez-Grande, Marat Slessarev, Ian Ball, Anna Geagea, Karen Burns, Alexandra Binnie, Sangeeta Mehta, Jennifer Tsang, Lisa Burry, Fred D'Aragon, Deborah Cook","doi":"10.1016/j.cct.2025.107938","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107938","url":null,"abstract":"<p><strong>Background: </strong>Objectives of this study were to determine the characteristics of patients, centers and studies involved in coenrollment, and the association of coenrollment with trial metrics and patient outcomes.</p><p><strong>Methods: </strong>This pre-planned study within a stress ulcer prophylaxis trial testing pantopazole used descriptive analyses and multilevel regression analysis to examine patterns and predictors of coenrollment among patients in an intensive care unit (ICU).</p><p><strong>Results: </strong>Among 4821 trial participants, 1719 (35.7 %) were coenrolled in at least one of 145 unique studies. There were 2167 coenrollment events. The most common design of coenrolled studies were individual-patient randomized trials, followed by cluster randomized trials and platform trials. Most coenrollment involved investigator-initiated studies (1924, 88.8 %). Patients with SARS-CoV-2 infection were more likely to be coenrolled than others (odds ratio 1.85 (95 % confidence interval, 1.50, 2.29), p < 0.001). Research coordinators with mid-senior trial experience were more likely to coenrol than others. Coenrolled patients were more likely to miss study drug (median 1 dose, IQR 1-2 doses) compared to others (202 (11.8 %) versus 221 (7.1 %), p < 0.001). Coenrollment did not influence the effect of pantoprazole on gastrointestinal bleeding or 90-day mortality.</p><p><strong>Conclusions: </strong>In the REVISE trial, one-third of participants were coenrolled, primarily into another academic randomized trial. Patients with SARS-CoV-2 were more likely to be coenrolled than other patients. Experienced research coordinators were more likely to coenrol than other personnel. Coenrollment did not modify the treatment effect of pantoprazole on the primary trial outcomes.</p><p><strong>Clinical trial registration: </strong>www.</p><p><strong>Clinicaltrials: </strong>govNCT03374800.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107938"},"PeriodicalIF":2.0,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial.","authors":"Craig Lammert, Siri Vuppalanchi, Kelsey Green, Nadia Blessing, Archita Desai, Timothy Stump, Nana Gletsu Miller, Lisa Spence, Amy Wright","doi":"10.1016/j.cct.2025.107951","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107951","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a debilitating symptom in patients with autoimmune hepatitis (AIH), and no effective treatment interventions are currently available. The anti-inflammatory properties of a Mediterranean diet (MD) may offer a potential non-pharmacological approach to reducing fatigue. This paper outlines the rationale, design, and protocol for a randomized crossover diet intervention trial to assess the effects of Mediterranean diet (MD) compared to a Western diet (WD) on fatigue levels in patients with AIH.</p><p><strong>Methods: </strong>In this crossover study, 48 subjects will be randomized to start either a MD or WD arm. After completing the initial arm, participants will switch to the opposite diet. The study team (including the PI and coordinator) and patients will remain blinded to the dietary intervention. The primary outcome will be the change in the fatigue component score of the PROMIS®-29 Profile v.2.0 survey during each dietary intervention. Secondary outcomes include changes in individual PROMIS-29 domain scores, mental and physical summary scores, circulating markers of inflammation (C-reactive protein and others), key liver serum biomarker levels (alanine aminotransferase, immunoglobulin G, total protein), stool microbiome (16S) and short-chain fatty acids, liver stiffness and steatosis, serum iron studies (ferritin, total iron binding capacity, transferrin saturation, hemoglobin), and nutritional markers such as serum vitamin D and magnesium levels.</p><p><strong>Conclusion: </strong>If the Mediterranean diet (MD) is associated with a statistically significant decrease in the fatigue component score of the PROMIS®-29 survey, it could serve as a promising non-pharmacological intervention to reduce fatigue in AIH patients, offering a novel approach to improve quality of life in this population.</p><p><strong>Clinicaltrials: </strong>gov ID: NCT06250309.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107951"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study.","authors":"Genevieve F Dunton, Lori Hatzinger, Rachel Crosley-Lyons, Micaela Hewus, Wei-Lin Wang, Delfien Van Dyck, Jimi Huh","doi":"10.1016/j.cct.2025.107945","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107945","url":null,"abstract":"<p><p>Physical activity interventions often fail to address features of physical activity that may lead to maintaining behavior, such as emotional experiences during behavior. Although some people experience pleasure during physical activity, it can be extremely unpleasant for others. Affective mechanisms (e.g., affective responses during behavior, anticipated affect about future behavior, affectively-charged motivations for future behavior) can influence the likelihood of engaging in future behavior. Using an experimental medicine approach, this Phase 1 trial of the eMOTION intervention aims to test whether affective mechanisms can be experimentally manipulated in real-world settings and whether affective mechanisms mediate the intervention effects on physical activity behavior. Pathways will be tested through a daily self-regulation intervention delivered using interactive mobile technology among physically inactive adults with overweight or obesity. An affect-based condition will provide daily goals related to enjoyment and feeling good during physical activity. In contrast, an intensity-based condition will provide daily goals for heart rate targets to achieve during physical activity. Two enhancements to the affect-based condition are: (1) tailored activity type and context recommendations to satisfy personally important psychological needs and (2) savoring practices to increase the saliency of positive emotions during physical activity. An 18-week study will optimize the treatment effects using a factorial (within x between) cross-over design (N = 280). Affective mechanisms and physical activity will be measured using real-time ecological momentary assessment (EMA) and accelerometry. Overall, this study fulfills an explicit need for the systematic translation of basic behavioral science processes into health behavioral change strategies through early-stage intervention development. Trial Registration Number: NCT06570642.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107945"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden in cancer survivors: The HINT II study protocol","authors":"Elyse R. Park ,&nbsp;Anne C. Kirchhoff ,&nbsp;Calli O. Mitchell ,&nbsp;Natalie Durieux ,&nbsp;Allyson Foor ,&nbsp;Karen Kuhlthau ,&nbsp;Giselle K. Perez ,&nbsp;Lakisa Ards ,&nbsp;Shani Alston ,&nbsp;Gregory T. Armstrong ,&nbsp;Perla L. Vaca Lopez ,&nbsp;Aaron McDonald ,&nbsp;Vikki G. Nolan ,&nbsp;Douglas E. Levy ,&nbsp;Wendy M. Leisenring ,&nbsp;Alison A. Galbraith ,&nbsp;Paul C. Nathan ,&nbsp;Chris Vukadinovich ,&nbsp;Christie L. Cooper ,&nbsp;Karen Donelan","doi":"10.1016/j.cct.2025.107952","DOIUrl":"10.1016/j.cct.2025.107952","url":null,"abstract":"<div><h3>Background</h3><div>Childhood cancer survivors often face high healthcare costs to monitor and manage new or lasting effects of their treatment. Enhancing survivors' health insurance literacy (HIL) – the knowledge, ability, and confidence in enrolling in and navigating health plans – is vital for minimizing financial burden. Few studies have assessed the effect of a health insurance navigation program on improving HIL among survivors. We present the protocol for an ongoing randomized controlled trial (RCT) assessing the effectiveness of two health insurance navigation programs (HINT-S and HINT-A) on improving HIL, financial burden, out-of-pocket costs, and healthcare utilization for adult survivors of childhood cancer.</div></div><div><h3>Methods</h3><div>This three-arm RCT assesses the effectiveness of two digitally delivered health insurance navigation interventions and enhanced usual care (EUC) on improving HIL at six and 12 months in a national cohort of childhood cancer survivors. While HINT-S is composed of five synchronous, navigator-led sessions, HINT-A is an asynchronous, prerecorded set of five videos. EUC participants receive only a health insurance informational booklet. Financial burden, medical out-of-pocket costs, and healthcare utilization (receipt of preventive care, recommended screenings/vaccinations, and acute care) are assessed at 12 months. Moderators to the interventions' effectiveness will be investigated, as well as implementation outcomes (feasibility, acceptability, appropriateness, fidelity, and cost-effectiveness).</div></div><div><h3>Conclusions</h3><div>There is a strong need for interventions to improve cancer survivors' HIL, helping them navigate the complexity of the U.S. healthcare system. This trial will elucidate the potential effectiveness and implementation of health insurance navigation programs that may benefit many cancer survivors.</div><div>Trial registration: <span><span>NCT05527392</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107952"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized, placebo-controlled trial of injectable extended-release naltrexone and injectable extended-release buprenorphine for cocaine use disorder (CURB-2): Study rationale and design","authors":"Madhukar H. Trivedi ,&nbsp;Mariah M. Kalmin ,&nbsp;Thomas Carmody ,&nbsp;Edward M. Chongsi ,&nbsp;Udi E. Ghitza ,&nbsp;Manish K. Jha ,&nbsp;Taryn L. Mayes ,&nbsp;Angela Casey-Willingham ,&nbsp;Sangita Sethuram ,&nbsp;Elise N. Marino ,&nbsp;Maria Monastirsky ,&nbsp;Steven J. Shoptaw","doi":"10.1016/j.cct.2025.107954","DOIUrl":"10.1016/j.cct.2025.107954","url":null,"abstract":"<div><h3>Background</h3><div>Cocaine remains the most abused stimulant, causing considerable morbidity and mortality. Despite decades of research, there is no FDA-approved medication to treat cocaine use disorder (CUD). In individuals with cocaine and opioid dependence/abuse, extended-release injectable naltrexone (XR-NTX) and sublingual buprenorphine (BUP; 16 mg with naloxone; Suboxone) reduced cocaine use compared to placebo and XR-NTX in the ‘Cocaine Use Reduction with Buprenorphine’ (CURB; CTN-0048) study.</div></div><div><h3>Objectives</h3><div>The CURB-2 (CTN-0109) study aims to examine whether administering XR-NTX in combination with extended-release injectable buprenorphine (XR-BUP), thus creating a “kappa antagonist,” is an effective pharmacotherapy compared to placebo for the treatment of CUD.</div></div><div><h3>Study design</h3><div>CURB-2 is a fully powered, phase IIb, randomized, placebo-controlled trial. Approximately 426 participants will be randomized across 12 study sites in the United States. There will be a 1-week medication induction phase, an 8-week active medication phase, and a 4-week follow-up phase. XR-NTX (Day 1, Week 3, Week 6) will be administered before XR-BUP (Day 4, Week 4). With naltrexone blocking the mu-opioid receptors, the reinforcing effects of buprenorphine will be blocked while leaving the kappa antagonist effects.</div></div><div><h3>Discussion</h3><div>If this kappa antagonist approach demonstrates efficacy in reducing urine-verified cocaine use compared to placebo, XR-NTX and XR-BUP combination therapy would be an important tool in addressing cocaine use disorder.</div><div>Clinical Trials Registration: <span><span>https://clinicaltrials.gov/ct2/show/NCT05262270</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107954"},"PeriodicalIF":2.0,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143947451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design","authors":"Mary Good ,&nbsp;Rachael Hoskins ,&nbsp;Brian C. Lund ,&nbsp;Patrick Ten Eyck ,&nbsp;Bradley Dixon ,&nbsp;Jordana Cohen ,&nbsp;Heather Reisinger Schact ,&nbsp;Korey Kennelty ,&nbsp;Diana Jalal","doi":"10.1016/j.cct.2025.107950","DOIUrl":"10.1016/j.cct.2025.107950","url":null,"abstract":"<div><h3>Rationale &amp; objective</h3><div>Chronic kidney disease (CKD) associates with high morbidity and mortality due to CKD progression and cardiovascular disease (CVD). Blood pressure (BP) lowering reduces the risk of CVD and CKD progression. Despite the large number of BP medications available, a significant proportion of patients with CKD have BP above the goal. The current practice involves licensed providers performing medication titrations to achieve BP goals and is associated with limited patient engagement. Here, we evaluate the effectiveness of pharmacist-guided patient-driven titration of BP medications in CKD.</div></div><div><h3>Study design</h3><div>Randomized clinical trial.</div></div><div><h3>Setting &amp; participants</h3><div>One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 or 4 CKD are recruited from the Iowa City VA Healthcare system.</div></div><div><h3>Interventions</h3><div>Subjects are randomized to the pharmacist self-guided management arm or the self-monitoring arm for 12 months.</div></div><div><h3>Outcomes</h3><div>This is a mixed methods study. The primary outcome is change in standardized office systolic BP at 12 months. Secondary outcomes include change in standardized office diastolic BP, change in home systolic and diastolic BPs, change in conventional office systolic and diastolic BPs, and emergency room visits for uncontrolled hypertension or hypertensive emergency. The study team will conduct semi-structured interviews to evaluate the acceptability and the adherence to the self-management approach to Veterans and to assess potential barriers and facilitators to implementation of the self-management approach.</div></div><div><h3>Trial Registration</h3><div><span><span>NCT05546099</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107950"},"PeriodicalIF":2.0,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Power considerations for the win ratio: A rank-based simulation approach","authors":"Lauren B. Bonner ,&nbsp;Jody D. Ciolino ,&nbsp;Keith S. Kaye ,&nbsp;Richard G. Wunderink ,&nbsp;Denise M. Scholtens","doi":"10.1016/j.cct.2025.107937","DOIUrl":"10.1016/j.cct.2025.107937","url":null,"abstract":"<div><h3>Background</h3><div>The win ratio is an innovative statistical method for evaluating efficacy in clinical trials. The underlying distributions of outcomes, along with potential censoring, ties, and correlations, add complexity to specifying a win ratio for study design purposes. As successful study planning hinges on thorough consideration of sample size and statistical power, we developed a flexible approach to support the use of the win ratio in clinical trials.</div></div><div><h3>Methods</h3><div>We develop a simulation-based approach for study design considerations, relying on the relationship between the win ratio and the rank distribution. We demonstrate that, in the absence of censoring and ties, the strategy samples according to the win ratio specified under the alternative hypothesis. We incorporate administrative censoring, ties, and correlations and conduct a simulation study to evaluate the method in terms of type I error and power. We generate data under specific parametric distributional assumptions and summarize statistical power using sample sizes determined by the rank-based simulation.</div></div><div><h3>Results</h3><div>Results indicate the proposed approach preserves type I error, samples under the assumed win ratio, and provides informative guidance on statistical power for given sample size. The winratiopss R package provides functionality to implement the proposed approach.</div></div><div><h3>Conclusions</h3><div>The simulation strategy offers a novel and flexible approach to inform trial design involving win ratio analysis.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107937"},"PeriodicalIF":2.0,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143929500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brain-targeted goal-directed therapy in high-risk patients undergoing major elective surgery: Study protocol for the BRAIN-PROMISE randomized trial","authors":"Massimiliano Greco ,&nbsp;Giulio Calgaro ,&nbsp;Mattia Cavallo ,&nbsp;Sara Pugliese ,&nbsp;Marta Mascari ,&nbsp;Fabio Piccirillo ,&nbsp;Andrea Pradella ,&nbsp;Federico Piccioni ,&nbsp;Maurizio Cecconi","doi":"10.1016/j.cct.2025.107940","DOIUrl":"10.1016/j.cct.2025.107940","url":null,"abstract":"<div><h3>Background</h3><div>Perioperative complications can lead to increased morbidity and mortality, diminished patient's quality of life, and substantial economic burden. Elderly and frail patients are particularly vulnerable, facing higher risks of postoperative cognitive dysfunction and delirium.</div><div>Perioperative choices and anaesthesia management, including hemodynamic monitoring, anaesthesia depth, and fluid therapy can significantly impact long-term outcomes. Near-infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation of brain tissue (rSO2) during surgery. Monitoring cerebral perfusion through rSO2 could estimate perfusion changes, identify early tissue hypoxia, and mitigate postoperative complications. Nonetheless, there is a lack of studies exploring NIRS-based hemodynamic optimization protocols in high-risk surgical populations.</div></div><div><h3>Object</h3><div>This prospective randomized controlled trial has been designed to evaluate whether NIRS-targeted goal-directed therapy can reduce rSO2 drop episodes and improve outcomes in high-risk elderly patients undergoing major surgery.</div></div><div><h3>Methods</h3><div>This randomized controlled trial will enroll hypertensive elderly patients aged ≥65 or with a clinical frailty score ≥ 5, undergoing moderate to high-risk surgery under general anaesthesia. Participants will be randomized 1:1 to either NIRS-targeted management or standard care, with NIRS monitoring applied to both groups but only guiding intervention in the experimental group, and with anesthesiologist blinded to NIRS value in control group. Primary outcomes include the overall incidence of perioperative complications at 30 days, secondary outcomes assess cognitive dysfunction, delirium, length of stay and mortality at 90 days.</div></div><div><h3>Conclusions</h3><div>This study presents an innovative approach on the effectiveness of NIRS-targeted goal directed for improving perioperative outcomes in high-risk elderly patients undergoing general anaesthesia.</div><div>Trial registration: <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> registration, n. <span><span>NCT04266574</span><svg><path></path></svg></span>,</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107940"},"PeriodicalIF":2.0,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}