Trials最新文献

{"title":"Inhaling penehyclidine to prevent perioperative respiratory adverse events in children at risk undergoing sevoflurane anesthesia (PEPSI trial): study protocol for a double-blind, randomized, placebo-controlled trial.","authors":"Yanling Zhu, Yongjian Mai, Yongyi Wang, Ting Huang, Jingxia Huang, Yiquan Lin, Dongsheng Zhao, Xiaoliang Gan","doi":"10.1186/s13063-026-09671-x","DOIUrl":"https://doi.org/10.1186/s13063-026-09671-x","url":null,"abstract":"<p><strong>Background: </strong>Perioperative respiratory adverse events (PRAEs) remain a challenge for pediatric anesthesia, inhalation of penehyclidine has been showed to reduce postoperative pulmonary complications and enhance the recovery in high-risk surgical adults. Thus, prophylactic penehyclidine inhalation might show promising benefits against PRAEs in children with high risk factors.</p><p><strong>Aims: </strong>To clarify the effectiveness of inhaling penehyclidine in reducing PRAEs in pediatric patients at risk scheduled for elective surgery following sevoflurane anesthesia with LMA.</p><p><strong>Methods: </strong>This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. Two hundred and four children, aged 3 to 7 years, undergoing elective minor ophthalmic surgery, who are at high risk of PRAEs, will be randomized in a ratio of 1:1 to receive either inhaling penehyclidine hydrochloride (PHC, a dose of 0.05 mg/kg, diluted and mixed with normal saline to a total volume of 5 ml) or identical volumes and colour of normal saline within 30 minutes prior to surgery. The primary outcome is the incidence of PRAEs. Secondary outcomes include the airway hyperreactivity (AHR) score, and the severity of laryngospasm and bronchospasm if occurs. Moreover, ease of laryngeal mask airway (LMA) insertion, episode and degree of salivation during removal of LMA, anesthesia-related recovery time, postoperative pain score, incidence of emergence agitation (EA), hemodynamic parameters, other postoperative adverse events related to the study drug within the first 24 postoperative hours, and the development of respiratory infections within 7 days after surgery will be also collected.</p><p><strong>Discussion: </strong>The results of this study will provide valuable insights into the potential role of inhaling PHC in reducing PRAEs in a high-risk pediatric cohort during sevofurane anesthesia with LMA, thereby promoting clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT06624696). Registered on 30 September 2024. https://clinicaltrials.gov/study/NCT06624696.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147609850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standard Therapy versus Plasmalyte in Children with Dengue Shock Syndrome (SPLID trial): a study protocol for an open-labeled randomized control trial.","authors":"Vidushi Mahajan, Neel Sandeep Shah, Tanya Vasudeva, Seema Gupta, Vishal Guglani","doi":"10.1186/s13063-026-09630-6","DOIUrl":"https://doi.org/10.1186/s13063-026-09630-6","url":null,"abstract":"<p><strong>Background: </strong>Intravenous fluid resuscitation is the first-line therapy in the management of dengue shock syndrome (DSS), a severe complication of dengue fever characterized by vascular leakage and organ dysfunction. However, the choice of intravenous fluids for resuscitation in DSS remains contentious. Evidence is lacking with regard to standard therapy, like normal saline (NS) and Ringer lactate (RL), versus newer balanced crystalloids like Plasmalyte (PL) for resuscitation of DSS.</p><p><strong>Methods: </strong>This study is a three-arm, prospective, open-label, parallel-group randomized clinical trial (RCT) to be conducted at a tertiary care hospital in north India over 36 months. We will recruit 135 children aged 2 months to 18 years, admitted with DSS who fulfill the eligibility criteria as per the WHO classification. The participants will be randomized to receive NS, or RL or PL in a 1:1:1 assignment. The primary outcome is a ≥5 mmol/L increase in serum chloride within 48 h post-randomization. The secondary outcomes include changes in acid-base status, hospital stay, need for colloid bolus, new-onset acute kidney injury (AKI), organ dysfunction, and mortality. AKI and organ dysfunction will be defined as per KDIGO criteria and Pediatric Logistic Organ Dysfunction 2 score (PELOD-2), respectively. Any serious adverse event occurring during the course of the trial will be reported to the ethics committee and the monitoring committee within 24 h. Both intention-to-treat and per-protocol analyses will be conducted.</p><p><strong>Discussion: </strong>DSS initially requires prompt fluid resuscitation with crystalloids. NS in large volumes may lead to hyperchloremic metabolic acidosis. RL, containing lactate as a buffer, is contraindicated in children with compromised liver function due to their reduced ability to metabolize lactate. PL, a balanced crystalloid, is isotonic with a chloride concentration similar to that of plasma. Thus, the RCT aims to determine the change in serum chloride between standard treatment vs. PL within 48 h of fluid resuscitation and to compare the change in acid-base status, hospital stay, new-onset AKI, organ dysfunction, and mortality in children with DSS.</p><p><strong>Trial registration: </strong>The SPLID trial has been registered prospectively with the Clinical Trial Registry of India (CTRI) registry no. CTRI/2023/11/060213 [Registered on 23/11/2023].</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147595048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-invasive vessel fractional flow reserve versus fractional flow reserve guidance to revascularize intermediate coronary stenosis (LIPSIA-STRATEGY) trial: study protocol for a randomized controlled trial.","authors":"Nicolas Majunke, Steffen Desch, Tobias Kister, Maria Buske, Janine Pöss, Hans-Josef Feistritzer, Sandra Erbs, Nadine Hösler, Janine Wolff, Steffen Schneider, Taoufik Ouarrak, Felix Woitek, Karsten Lenk, Holger Nef, Oliver Dörr, Samuel Sossalla, Stephan Achenbach, Mohamed Marwan, Dimitrios Barlagiannis, Michael Haude, Amir Abbas Mahabadi, Tienush Rassaf, Holger Thiele","doi":"10.1186/s13063-026-09652-0","DOIUrl":"10.1186/s13063-026-09652-0","url":null,"abstract":"<p><strong>Background: </strong>Current guidelines on coronary revascularization support the use of wire-based coronary physiology measurements to guide decision making in patients with coronary artery stenoses. Nevertheless, the use of these techniques in clinical practice is variable and its application worldwide remains limited by its requirement for the use of an intracoronary pressure wire and prolonged procedure time. Recently, angiography-based wire-free techniques to estimate fractional flow reserve (FFR) values have been introduced. These developments may translate towards more physiology-guided intervention bearing the potential to improve clinical outcomes in patients with stable coronary artery disease (CAD).</p><p><strong>Methods: </strong>The LIPSIA-STRATEGY trial is a randomized controlled, investigator-initiated, multicenter, open-label study. A total of 1054 eligible patients will be randomized 1:1 to coronary revascularization based on angiography-derived vessel fractional flow reserve (vFFR) or revascularization based on FFR obtained by pressure wire measurements. The major inclusion criterion is the presence of visually assessed intermediate coronary artery stenoses in one or more native major epicardial coronary arteries in the setting of stable angina or an acute coronary syndrome (ACS). In patients with an ACS, only non-culprit vessels will be considered for inclusion. The primary endpoint is the occurrence of major adverse cardiovascular events (MACE) during the first year after randomization.</p><p><strong>Discussion: </strong>The LIPSIA-STRATEGY trial will be the first to compare angiography-derived vFFR with invasive FFR with respect to clinical outcomes in patients with intermediate coronary lesions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03497637. Registered 2018-04-13.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147595081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimation of combined treatment effects by restricted mean survival time.","authors":"Emily Alger, David S Robertson, Abigail J Burdon","doi":"10.1186/s13063-026-09666-8","DOIUrl":"https://doi.org/10.1186/s13063-026-09666-8","url":null,"abstract":"<p><strong>Background: </strong>Restricted mean survival time (RMST) endpoints are becoming commonly used as trialists look to analyse time-to-event outcomes without the restrictions of the proportional hazards assumption. An additional benefit of RMST endpoints which has so far remained unexplored is their capability to combine treatment main effects and treatment-by-covariate interaction terms into single one-dimensional estimators under both proportional and non-proportional hazards. By utilising RMST estimators, trialists may assess treatment effects associated with multiple covariates, including interaction terms - an inherent limitation of proportional hazards models when this assumption is violated.</p><p><strong>Methods: </strong>We present a simulation study using a case study of a randomised controlled trial of Gamma interferon for the treatment of chronic granulomatous disease. We evaluate the power and type I error rate of parametric and non-parametric RMST estimators of combined treatment effects under both proportional and non-proportional hazards. Performance is evaluated when the model or the knot point is specified correctly or misspecified. We also explore the effect of truncation time.</p><p><strong>Results: </strong>Simulations show that parametric RMST estimators offer greater power when covariate effects and knot-point locations are correctly specified or only mildly misspecified. However, their performance deteriorates as omitted covariate effects increase or knot locations become more misspecified. Under substantial misspecification, the non-parametric estimator is more robust, maintaining stable type I error rates and improved power. For the non-parametric approach, power increases with later truncation times.</p><p><strong>Conclusions: </strong>This paper demonstrates the role of RMST estimators for survival analysis in the presence of main treatment effects and treatment-by-covariate interactions - highlighting the utility of RMST estimators in the analysis of trials with combined treatment effects. This paper offers further practical guidance on the strengths and limitations of parametric and non-parametric RMST estimators in the presence of model misspecification. It also serves as a case study for trialists wishing to explore RMST estimators by simulations tailored to their own research context.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147595025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"SWAT 119: the effectiveness of a Thank You card to improve trial follow-up; a randomised study within a trial (SWAT).","authors":"S Zahra, F Wiggins, T Yakimova, K Baird, I Chetter, C Fairhurst, A Mott, S Swan, J Wilkinson, C E Arundel","doi":"10.1186/s13063-026-09636-0","DOIUrl":"https://doi.org/10.1186/s13063-026-09636-0","url":null,"abstract":"<p><strong>Background: </strong>Retention in randomised controlled trials is crucial to maximising study power and generalisability. A Study Within A Trial (SWAT) evaluated if sending a Thank You card improved 6-month questionnaire return rates in the SWHSI-2 trial.</p><p><strong>Methods: </strong>A two-arm SWAT, using 1:1 (intervention:control) allocation, embedded within the SWHSI-2 trial. The primary outcome was the difference in the return rate of the 6-month questionnaire. Secondary outcomes were the difference in return rate of the 12-month questionnaire, questionnaire completeness, need for a reminder, and cost. The primary analysis was conducted using mixed-effects logistic regression adjusted for main trial allocation as a fixed effect and site as a random effect. Random-effects meta-analysis combined all available data for this intervention.</p><p><strong>Results: </strong>A total of 560 participants were included in the SWAT. There was no difference in the 6-month questionnaire return rate between the Thank You card group and the no Thank You card group (OR 1.04, 95% CI 0.73 to 1.50, p = 0.87). The 12-month retention rate was slightly higher in the Thank You card group, but the difference was not statistically significant (OR 1.15, 95% CI 0.81 to 1.62, p = 0.43). Findings were very similar in sensitivity analyses accounting for intervention participants who did not receive their card. There was no evidence of difference for any of the remaining secondary outcomes. Meta-analysis of the 12-month return rate suggests that Thank You cards may provide slight improvements in questionnaire response rates; however there is uncertainty in this estimate (OR 1.07, 95% CI 0.79 to 1.45).</p><p><strong>Conclusion: </strong>It remains unclear if a Thank You card increased the rate of 6-month follow-up questionnaire completion in the SWHSI-2 trial. This is further amplified by the limited number of SWAT replications completed to date and included in the meta-analysis (n=2). The SWATs to date have primarily been undertaken in trials with a predominantly older, white, male, population. Further SWAT replications are therefore required in other populations to ensure generalisability of a cumulative SWAT finding.</p><p><strong>Trial registration: </strong>Host Trial: ISRCTN26277546. Prospectively registered on 25^th March 2019. SWAT: MRC Hub for Trials Methodology Research SWAT repository #119 can be found at: https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,959362,en.pdf.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of transcranial direct current stimulation and neural mobilization on pain and disability in people with chronic radicular pain: a protocol for a sham-controlled randomized trial.","authors":"Aryostennes Miquéias da Silva Ferreira, César Augusto Medeiros Silva, Rodrigo Pegado de Abreu Freitas, Liane de Brito Macedo, Clécio Gabriel de Souza","doi":"10.1186/s13063-025-09417-1","DOIUrl":"https://doi.org/10.1186/s13063-025-09417-1","url":null,"abstract":"<p><strong>Background: </strong>Radicular pain is a very common condition that occurs when spine discopathy leads to nerve root damage; it radiates to the leg with somatotopic distribution. It could cause high levels of pain and disability. When it becomes chronic, central sensitization may be present, which can lead to neuropathic pain. Neural mobilization is a manual approach recommended for the treatment of this condition. Transcranial direct current stimulation (tDCS) has emerged as an alternative treatment for neuropathic chronic pain in an attempt to modulate brain function. The aim of this study is to verify if the effects of tDCS add benefits in decreasing pain intensity, neuropathic symptoms, and disability in individuals with chronic radicular pain when associated with neural mobilization.</p><p><strong>Methods: </strong>It is a protocol for a randomized controlled trial to be conducted with individuals with chronic radicular pain divided in two groups: Experimental group (active tDCS + neural mobilization) and control group (sham tDCS + neural mobilization). The primary outcome will be pain intensity, measured through the numerical pain scale; secondary outcomes are disability, assessed by Roland Morris, and neuropathic symptoms, assessed by Douleur Neuropathique Questionnaire and Pain Detect Questionnaire, range of motion on the Single Leg Raise Test, pressure pain threshold, and two-point discrimination. Perceived Global Effect Scale will also be used. The assessment will be performed before and after the five consecutive days' intervention protocol and at 7 and 14 days of follow-up for pain intensity. Data will be analyzed by SPSS software; Kolmogorov-Smirnov and Levene tests will be applied to verify the normality and homogeneity of the sample. Then, a repeated measure ANOVA will be performed for comparison over time. A statistical significance level of 5% and a 95% confidence interval will be assumed.</p><p><strong>Discussion: </strong>This study would elucidate the possible tDCS effects on radicular pain, which could be pointed out as a new therapeutic tool for this difficult management condition.</p><p><strong>Trial registration number: </strong>RBR-2d3jj9t/U1111-1289-8248 REBEC. Registered on 04/06/2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving primary healthcare for non-communicable diseases during annual flooding in Bihar, India: study protocol for a hybrid implementation-effectiveness parallel cluster randomised controlled trial.","authors":"Semira Manaseki-Holland, Tanvir Ahmed, Ratna Amrit, Steven Blackburn, Sunny Borgohain, Nupur Bose, Dorairaj Prabhakaran, Ashok Ghosh, Sheila Greenfield, Shasha Han, Linju Joseph, Rachel Jordan, Sue Jowett, Stefan Krause, Nishant Kumar, Suresh Munuswamy, Poornima Prabhakaran, Gavin Roudge, Benjamin Ryan, Ajay Kumar Shahi, Rahul Shidhaye, Ravikant Singh, Manu Muraleedharan Sarojini, Tulika Singh, Ashuthosh Sharma, Alice Sitch, Jissa Vinoda Thulaseedharan, Jacqueline Y Thompson, Martin Widmann, Brijesh Kumar Yadav, Panniyammakal Jeemon","doi":"10.1186/s13063-026-09633-3","DOIUrl":"https://doi.org/10.1186/s13063-026-09633-3","url":null,"abstract":"<p><strong>Background: </strong>Non-communicable diseases (NCDs) cause 4.7 million deaths annually in India. Floods increasingly disrupt NCD care, especially in Bihar, one of India's most flood-prone and socioeconomically disadvantaged states. This study aims to strengthen the capacity of the community and primary healthcare systems to improve NCD outcomes during annual flooding in Bihar.</p><p><strong>Methods: </strong>We describe a type II, hybrid implementation-effectiveness parallel cluster randomised controlled trial with an embedded qualitative process evaluation. A multi-component, co-developed intervention targeting primary care and community settings will be implemented and evaluated over two flood seasons in 26 flood-prone community development blocks in three districts of Bihar. Normalisation Process Theory (NPT) will guide the interpretation and adaptation of the intervention for broader applicability. Data will be collected through baseline and follow-up cross-sectional surveys conducted immediately after and 6 months following each annual flood season. Mixed-methods implementation and effectiveness outcomes will be evaluated using the RE-AIM-QuEST (Reach, Effectiveness, Adoption, Implementation, and Maintenance, Qualitative Evaluation for Systematic Translation) framework. Co-primary outcomes are patient medication adherence and availability of a flood-proof kit with medication and clinical handover information during floods. A preliminary health economic evaluation will estimate the cost-effectiveness of the intervention from a healthcare and societal perspective, with and without the use of early-warning flood forecasting.</p><p><strong>Conclusion: </strong>The FUSION (Floods, UnderStanding clImate change and nON communicable disease) trial will generate evidence on effective and scalable strategies to enhance health system and community resilience for the continuity of NCD care during recurrent flooding in India. Findings will inform public health policy and disaster preparedness efforts in similar resource-constrained, climate-vulnerable settings.</p><p><strong>Trial registration: </strong>CTRI/2025/07/092055 [Registered on 30/07/2025] http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=138142; ISCTRN18019775 [Registered on 12/08/2025] https://www.isrctn.com/ISRCTN18019775.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147595074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Intubation of obese patients in the operating room with or without bag-mask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT).","authors":"Souhaïl Znaïdi, Romain Deransy, Karim Asehnoune, Marguerite Le Penndu, Bertrand Rozec, Guillaume Jumel, Sigismond Lasocki, Anna Cadic-Pelletier, Pierre-Grégoire Guinot, Alexis Duchalais, Cédric Cirenei, Stanislas Abrard, Hélène Beloeil, Camille Fortuit, Jérôme Landrin, Guillaume Porta Bonete, Fanny Defrancq, Morgane Péré, Mickaël Vourc'h","doi":"10.1186/s13063-026-09662-y","DOIUrl":"10.1186/s13063-026-09662-y","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13034584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147582368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Personalized hemodynamic management targeting preoperative baseline cardiac index in high-risk patients having major abdominal surgery: rationale and design of the international multicenter randomized PELICAN trial.","authors":"Moritz Flick, Eske Kvanner Aasvang, Michael Eichlseder, Adam Klimovic, Agnes S Meidert, Christian Sylvest Meyhoff, Sebastian Roth, Moritz Steinhaus, Rune Sort, Marc Vives, Benjamin Vojnar, Sebastian Ziemann, Linda Krause, Eik Vettorazzi, Antonia Zapf, Karim Kouz, Bernd Saugel","doi":"10.1186/s13063-026-09657-9","DOIUrl":"10.1186/s13063-026-09657-9","url":null,"abstract":"<p><strong>Background: </strong>Intraoperative hemodynamic management is intended to ensure adequate tissue perfusion and oxygen delivery and eventually help avoid organ injury. However, the optimal strategy for intraoperative hemodynamic management in patients having non-cardiac surgery remains unclear. We here report the protocol of a trial designed to test the hypothesis that personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of a composite outcome of major postoperative complications and death within 7 days after surgery compared to routine hemodynamic management in high-risk patients having elective major abdominal surgery.</p><p><strong>Methods: </strong>The PELICAN trial is an international multicenter randomized trial in 1,128 high-risk patients having elective major abdominal surgery. The individual preoperative baseline cardiac index is determined with the patient being awake and resting in the supine position using noninvasive bioreactance. Patients are randomized to personalized hemodynamic management (intervention) or to routine hemodynamic management (control) during surgery. In patients assigned to personalized hemodynamic management, intraoperative cardiac index is maintained at least at the preoperative baseline cardiac index. In patients assigned to routine hemodynamic management, it is performed as per anesthesiologist preference (with blinded cardiac index monitoring). The primary outcome is the incidence of a composite outcome (\"any event versus none\") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, severe infectious complications, and death within 7 days after surgery.</p><p><strong>Discussion: </strong>Our trial will determine whether personalized intraoperative hemodynamic management targeting preoperative baseline cardiac index reduces the incidence of major postoperative complications and death within 7 days in high-risk patients having elective major abdominal surgery compared to routine hemodynamic management.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier NCT05648279. Registered on 5 December 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064272/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Nutritional management of growth faltering in infants aged under six months in Asia and Africa: study protocol for a multicentre randomised trial (BRANCH, BReAstfeediNg Counselling and management of growtH).","authors":"","doi":"10.1186/s13063-026-09667-7","DOIUrl":"10.1186/s13063-026-09667-7","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13032272/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147532483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}