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. 2025 Oct 12:e2517235.
doi: 10.1001/jama.2025.17235. Online ahead of print.

Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial

Bernd Saugel  1   2 , Agnes S Meidert  3 , Frank M Brunkhorst  4 , Robert Bischoff  5 , Joseph Esser  3 , Minca Mattis  6 , Pauline Naue  3 , Katharina Vogel  3 , Alina Bergholz  1 , Moritz Flick  1 , Alina Kröker  1 , Dominik X Müller  1 , Kristen K Thomsen  1 , Christina Vokuhl  1 , Mirja Wegge  1 , Sebastian Bratke  7 , Martin Graeßner  7 , Bettina Jungwirth  7 , Sebastian Schmid  7 , Carla D Grundmann  8 , Jan M Wischermann  8 , Patrick Kellner  9 , Moritz Steinhaus  9 , Linda Grüßer  10 , Sina M Coldewey  4   11   12 , Kai Zacharowski  13 , Patrick Meybohm  14 , Marit Habicher  15 , Alexander Zarbock  16   17 , Amelie Zitzmann  18 , Svenja Letz  19 , Claudia Neumann  20 , Jan Larmann  10   21 , Thomas Renné  22   23 , Linda Krause  24 , Eik Vettorazzi  24 , Antonia Zapf  24 , Annemarie Carlstedt  25 , Daniel I Sessler  2   26 , Karim Kouz  1   2 ; IMPROVE-multi Trial Group
Collaborators, Affiliations

Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial

Bernd Saugel et al. JAMA. .

Abstract

Importance: Intraoperative hypotension is associated with organ injury. However, it remains unknown if targeted blood pressure management during surgery can improve clinical outcomes.

Objective: To evaluate whether individualized vs routine perioperative blood pressure management during major abdominal surgery improves clinical outcomes in patients considered at high risk of postoperative complications.

Design, setting, and participants: This randomized single-blind clinical trial enrolled patients 45 years or older undergoing elective major abdominal surgery with general anesthesia expected to last 90 minutes or longer who had at least 1 additional high-risk criterion between February 26, 2023, and April 25, 2024, at 15 German university hospitals. The date of last follow-up was July 25, 2024.

Intervention: Patients were randomized in a 1:1 ratio to individualized perioperative blood pressure management (with mean arterial pressure [MAP] targets based on preoperative mean nighttime MAP assessed using automated blood pressure monitoring) or routine blood pressure management with a MAP target of 65 mm Hg or higher.

Main outcomes and measures: The primary outcome was the incidence of a composite outcome of acute kidney injury, acute myocardial injury, nonfatal cardiac arrest, or death within the first 7 postoperative days. There were 22 secondary outcomes, including infectious complications within the first 7 postoperative days and a composite outcome of need for kidney replacement therapy, myocardial infarction, nonfatal cardiac arrest, or death within 90 days after surgery.

Results: Of the 1272 patients enrolled, 1142 were randomized (571 patients to each group), and 1134 were included in the primary analysis (median age, 66 years [IQR, 59-73 years]; 34.1% female). The primary outcome occurred in 190 of 567 patients (33.5%) assigned to individualized blood pressure management and 173 of 567 patients (30.5%) assigned to routine blood pressure management (relative risk, 1.10 [95% CI, 0.93-1.30]; P = .31). None of the 22 secondary outcomes were significantly different, including infectious complications within the first 7 postoperative days (90/567 [15.9%] vs 97/567 [17.1%]; P = .63) and a composite outcome of need for kidney replacement therapy, myocardial infarction, nonfatal cardiac arrest, or death within 90 days after surgery (32/566 [5.7%] vs 20/567 [3.5%]; P = .12).

Conclusions and relevance: Among patients at high risk of postoperative complications undergoing major abdominal surgery, individualized perioperative blood pressure management with MAP targets based on preoperative mean nighttime MAP did not decrease the composite outcome of acute kidney injury, acute myocardial injury, nonfatal cardiac arrest, or death within the first 7 postoperative days compared with routine blood pressure management with a MAP target of 65 mm Hg or higher.

Trial registration: ClinicalTrials.gov Identifier: NCT05416944.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Saugel reported receiving grants from Edwards Lifesciences, Baxter, GE Healthcare, CNSystems Medizintechnik, Pulsion Medical Systems, Vygon, Retia Medical, and Osypka Medical; serving as editor for the British Journal of Anaesthesia; and receiving personal fees from Edwards Lifesciences, Philips, GE Healthcare, Maquet Critical Care, Pulsion Medical Systems, Vygon, Retia Medical, Masimo, Dynocardia, Baxter, CNSystems Medizintechnik, Getinge, and ratiopharm outside the submitted work. Dr Meidert reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving lecture honoraria from Edwards Lifesciences outside the submitted work. Dr Brunkhorst reported receiving personal fees for serving as an advisory board member for Bosch Healthcare Solutions and Adrenomed outside the submitted work. Dr Bischoff reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Esser reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Mattis reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Ms Naue reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Ms Vogel reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Flick reported receiving personal fees from Edwards Lifesciences and Vygon outside the submitted work. Dr Thomsen reported receiving personal fees from Masimo outside the submitted work. Dr Bratke reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Graeßner reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Jungwirth reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving an institutional restricted research grant from Löwenstein Medical Innovation outside the submitted work. Dr Schmid reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Grundmann reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving personal fees from Edwards Lifesciences/Becton Dickinson, and TEVA outside the submitted work. Dr Wischermann reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving personal fees from Edwards Lifesciences/Becton Dickinson and Haemonetics outside the submitted work. Dr Kellner reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study; receiving consulting and lecture honoraria from Sedana Medical; receiving travel fees from Sedana Medical and Edwards Lifesciences; and receiving personal fees from Edwards Lifesciences outside the submitted work. Dr Steinhaus reported receiving initiation and case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving a travel grant from Edwards Lifesciences outside the submitted work. Dr Grüßer reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Coldewey reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Zacharowski reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study; receiving grants from Vifor, Fresenius, CSL, and B. Braun; receiving personal fees for serving on advisory boards for Haemonetics and Vifor; receiving speaking fees from CSL Behring, Hattersheim, Masimo, Pharmacosmos, Boston Scientific, Salus, iSEP, Edwards, Hemasonics, and GE Healthcare; receiving grants from EU-Horizon 2020 project ENVISION (intelligent plug-and-play digital tool for real-time surveillance of patients with COVID-19 and smart decision-making in intensive care units), Horizon Europe 2021 project COVend (biomarker and artificial intelligence–supported FX06 therapy to prevent progression from mild and moderate to severe stages of COVID-19), and EU Horizon 2023 project EDiHTA; and serving as chief executive officer of the Christoph Lohfert Foundation and the Health, Patient Safety and Pharmacy Benefit Management Foundation outside the submitted work. Dr Meybohm reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study; receiving grants from the Federal Ministry of Education and Research and the Federal Ministry of Health; receiving personal fees from Biotest, CSL Behring, Pharmacosmos, and CSL Vifor; serving on the boards of directors for the Foundation for Health, Patient Safety and Patient Blood Management and the Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis; and serving as a member of the working group of the “Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives” scientific advisory board outside the submitted work. Dr Habicher reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving honoraria from Edwards Lifesciences for consulting outside the submitted work and from Edwards Lifesciences and Baxter for lectures outside the submitted work. Dr Zarbock reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study; receiving grants from Baxter, BioMerieux, Fresenius, the German Research Foundation; and the Federal Ministry of Education and Research outside the submitted work; and receiving personal fees from Baxter, AM Pharma, Paion, Viatris, Bayer, Novartis, BioMerieux, Alexion, Guard Therapeutics, Renibus outside the submitted work. Dr Zitzmann reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving grants and speakers honoraria from Edwards Lifesciences outside the submitted work. Dr Letz reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study. Dr Neumann reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study; receiving case payments from ratiopharm, Philips Medizin Systeme Böblingen, Queen Mary University of London, and the Population Health Research Institute outside the submitted work. Dr Larmann reported receiving case payments from University Medical Center Hamburg–Eppendorf during the conduct of the study and receiving expenditures paid to institution from Philips Medizin Systeme Böblingen for education services and training of Philips employees outside the submitted work. Dr Sessler reported holding equity in Perceptive Medical and receiving fees from Dynocardia (paid directly to charity) outside the submitted work. Dr Kouz reported receiving personal fees from Edwards Lifesciences and Vygon outside the submitted work. No other disclosures were reported.

Comment in

  • doi: 10.1001/jama.2025.18572

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