Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi)

Trials

Study Protocol

Frank M. Brunkhorst¹  Kai Zacharowski²  Agnes S. Meidert³  Moritz Flick⁴  Karim Kouz⁴  Alina Bergholz⁴  Bernd Saugel⁵  Patrick Meybohm⁶  Alexander Zarbock⁷  Daniel I. Sessler⁸  Eik Vettorazzi⁹  Linda Krause⁹  Antonia Zapf⁹ 

[1] Center for Clinical Studies, Jena University Hospital, Jena, Germany;Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany;Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany;Department of Anaesthesiology, University Hospital LMU Munich, Munich, Germany;Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany;Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany;Outcomes Research Consortium, Cleveland, OH, USA;Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany;Department of Anesthesiology, Intensive Care, and Pain Medicine, University Hospital Münster, Münster, Germany;Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA;Outcomes Research Consortium, Cleveland, OH, USA;Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;

关键词: anesthesia;    cardiovascular dynamics;    hemodynamic monitoring;    individualized, randomized controlled trial;   

DOI  :  10.1186/s13063-022-06854-0

 received in 2022-09-27, accepted in 2022-10-19,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundIntraoperative hypotension is common in patients having non-cardiac surgery and is associated with serious complications and death. However, optimal intraoperative blood pressures for individual patients remain unknown. We therefore aim to test the hypothesis that personalized perioperative blood pressure management—based on preoperative automated blood pressure monitoring—reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.MethodsIMPROVE-multi is a multicenter randomized trial in 1272 high-risk patients having elective major abdominal surgery that we plan to conduct at 16 German university medical centers. Preoperative automated blood pressure monitoring using upper arm cuff oscillometry will be performed in all patients for one night to obtain the mean of the nighttime mean arterial pressures. Patients will then be randomized either to personalized blood pressure management or to routine blood pressure management. In patients assigned to personalized management, intraoperative mean arterial pressure will be maintained at least at the mean of the nighttime mean arterial pressures. In patients assigned to routine management, intraoperative blood pressure will be managed per routine. The primary outcome will be a composite of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery.DiscussionOur trial will determine whether personalized perioperative blood pressure management reduces the incidence of major postoperative complications and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.Trial registrationClinicalTrials.gov NCT05416944. Registered on June 14, 2022.

【 授权许可】

CC BY   
© The Author(s) 2022. corrected publication 2023

【 图 表 】

Fig. 3