Perioperative Personalized Blood Pressure Management: IMPROVE-multi

NCT ID: NCT05416944

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-26
• Study Completion Date: 2024-07-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Routine management (control) group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Personalized management (intervention) group

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.

Group Type: EXPERIMENTAL

Personalized blood pressure management

Intervention Type: 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.

Interventions

Personalized blood pressure management

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• age ≥65 years
• expected anesthesia duration >180 minutes
• B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Saugel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Locations

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

Hamburg, , Germany

Countries

Germany

References

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

Reference Type: DERIVED

PMID: 41076588 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36397173 (View on PubMed)

Other Identifiers

ZKSJ0147

Identifier Type: -

Identifier Source: org_study_id