NCT05416944: IMPROVE

Perioperative Personalized Blood Pressure Management: IMPROVE-multi

Completed NA Last updated 11 December 2024

What this trial tests

NA trial testing Personalized blood pressure management in Blood Pressure in 1,272 participants. Completed in 25 July 2024.

Timeline

26 February 2023

Primary endpoint
25 May 2024

25 July 2024

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	1,272
Start date	26 February 2023
Primary completion	25 May 2024
Estimated completion	25 July 2024
Sites	1 location across Germany

Drugs / interventions tested

• Personalized blood pressure management

Conditions studied

• Blood Pressure — all drugs for Blood Pressure →
• Intraoperative Hypotension — all drugs for Intraoperative Hypotension →
• Postoperative Complications — all drugs for Postoperative Complications →
• Surgery — all drugs for Surgery →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

18 and older, any sex, with Blood Pressure or Intraoperative Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. PeriOperative Quality Initiative (POQI) international consensus statement on perioperative arterial pressure management.
   Saugel B, Fletcher N, Gan TJ, Grocott MPW, et al · · 2024 · cited 80× · PMID 38839472 · DOI 10.1016/j.bja.2024.04.046
2. 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).
   Bergholz A, Meidert AS, Flick M, Krause L, et al · · 2022 · cited 28× · PMID 36397173 · DOI 10.1186/s13063-022-06854-0
3. Individualized Perioperative Blood Pressure Management in Patients Undergoing Major Abdominal Surgery: The IMPROVE-multi Randomized Clinical Trial.
   Saugel B, Meidert AS, Brunkhorst FM, Bischoff R, et al · · 2025 · cited 18× · PMID 41076588 · DOI 10.1001/jama.2025.17235
4. Association of intraoperative hypotension and acute kidney injury in noncardiac surgery patients: a post hoc secondary analysis of the EU HYPROTECT registry.
   Runge J, Grundmann CD, Mucha C, Denz R, et al · · 2026 · cited 4× · PMID 40676457 · DOI 10.1007/s10877-025-01329-4
5. Effect of individualized versus conventional perioperative blood pressure management on postoperative major complications in high-risk patients undergoing noncardiac surgery: study protocol for the SPROUT-4 multicenter randomized controlled trial.
   Chung J, Koo CH, Park J, Kim HB, et al · · 2024 · cited 1× · PMID 39725988 · DOI 10.1186/s13063-024-08707-4
6. A global perspective on acute kidney injury after major surgery: much needed insights and sobering results.
   Saugel B, Hoste E, Chew MS. · · 2023 · cited 1× · PMID 37906259 · DOI 10.1007/s00134-023-07250-1