Perioperative Personalized Blood Pressure Management: IMPROVE-multi

NCT05416944 | Completed DMC

• 1 other identifier: ZKSJ0147
• Study Type: interventional
• Target: 1,272
• Locations: 1 country
• Sites: 1

Brief Summary

Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management 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. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.

Conditions

Blood Pressure; Intraoperative Hypotension; Postoperative Complications; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Composite outcome of major postoperative complications

  Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery

  Postoperative Day 7

Secondary Outcomes (33)

• Composite outcome of major postoperative complications

  Postoperative Day 3

• Postoperative acute kidney injury

  Postoperative Day 3

• Postoperative acute kidney injury

  Postoperative Day 7

• Postoperative acute myocardial injury (including myocardial infarction)

  Postoperative Day 3

• Postoperative acute myocardial injury (including myocardial infarction)

  Postoperative Day 7

Study Arms (2)

Routine management (control) group

NO INTERVENTION

Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients assigned to the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring.

Personalized management (intervention) group

EXPERIMENTAL

In patients randomized to the personalized management group, intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. The perioperative trial intervention period starts with the beginning of the induction of general anesthesia and ends two hours after surgery ends.

Other: Personalized blood pressure management

Interventions

Personalized blood pressure management OTHER

Personalized blood pressure management: Intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg.

Personalized management (intervention) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients ≥45 years scheduled for elective major abdominal surgery under general anesthesia that is expected to last ≥90 minutes AND
• Presence of ≥1 of the following high-risk criteria:
• exercise tolerance \<4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
• renal impairment (serum creatinine ≥1.3 mg/dL or estimated glomerular filtration rate \<90 mL/min/1.73 m2 within the last 6 months)
• coronary artery disease (any stage)
• chronic heart failure (New York Heart Association Functional Classification ≥II)
• valvular heart disease (moderate or severe)
• history of stroke
• peripheral arterial occlusive disease (any stage)
• chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
• diabetes mellitus requiring oral hypoglycemic agent or insulin
• immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids \[above Cushing threshold\])
• liver cirrhosis (any Child-Pugh class)
• body mass index ≥30 kg/m2
• current smoking or 15 pack-year history of smoking

You may not qualify if:

• emergency surgery
• surgery: nephrectomy, liver or kidney transplantation
• status post transplantation of kidney, liver, heart, or lung
• sepsis (according to current Sepsis-3 definition)
• American Society of Anesthesiologists physical status classification V or VI
• pregnancy
• patients on renal replacement therapy
• impossibility of preoperative automated blood pressure monitoring

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Jena University Hospital: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

• Saugel B, Meidert AS, Brunkhorst FM, Bischoff R, Esser J, Mattis M, Naue P, Vogel K, Bergholz A, Flick M, Kroker A, Muller DX, Thomsen KK, Vokuhl C, Wegge M, Bratke S, Graessner M, Jungwirth B, Schmid S, Grundmann CD, Wischermann JM, Kellner P, Steinhaus M, Grusser L, Coldewey SM, Zacharowski K, Meybohm P, Habicher M, Zarbock A, Zitzmann A, Letz S, Neumann C, Larmann J, Renne T, Krause L, Vettorazzi E, Zapf A, Carlstedt A, Sessler DI, Kouz K; IMPROVE-multi Trial Group. Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial. JAMA. 2025 Dec 2;334(21):1893-1904. doi: 10.1001/jama.2025.17235.

  PMID: 41076588 DERIVED

• Bergholz A, Meidert AS, Flick M, Krause L, Vettorazzi E, Zapf A, Brunkhorst FM, Meybohm P, Zacharowski K, Zarbock A, Sessler DI, Kouz K, Saugel B. 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. 2022 Nov 17;23(1):946. doi: 10.1186/s13063-022-06854-0.

  PMID: 36397173 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernd Saugel, M.D.

  Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In patients in the routine management group, the treating anesthesiologists will be blinded to data of preoperative automated blood pressure monitoring to avoid performance bias. Participants are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 14, 2022
• Study Start: February 26, 2023
• Primary Completion: May 25, 2024
• Study Completion: July 25, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-04

Locations

DE (1)