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Perioperative Personalized Blood Pressure Management: IMPROVE-multi

Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05416944
Acronym
IMPROVE
Enrollment
1272
Registered
2022-06-14
Start date
2023-02-26
Completion date
2024-07-25
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

Sponsors

Jena University Hospital
CollaboratorOTHER
The Cleveland Clinic
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite outcome of major postoperative complicationsPostoperative Day 7Collapsed 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

Secondary

MeasureTime frameDescription
Postoperative acute kidney injuryPostoperative Day 3Incidence of acute kidney injury within 3 days after surgery
Postoperative acute myocardial injury (including myocardial infarction)Postoperative Day 3Incidence of acute myocardial injury (including myocardial infarction) within 3 days after surgery
Postoperative non-fatal cardiac arrestPostoperative Day 3Incidence of non-fatal cardiac arrest within 3 days after surgery
Postoperative deathPostoperative Day 3Incidence of death within 3 days after surgery
Composite outcome of long-term postoperative complicationsPostoperative Day 30Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery
Postoperative need for renal replacement therapyPostoperative Day 30Incidence of need for renal replacement therapy within 30 days after surgery
Postoperative myocardial infarctionPostoperative Day 30Incidence of myocardial infarction within 30 days after surgery
Postoperative infectious complicationsPostoperative Day 7Collapsed incidence of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery
Postoperative feverPostoperative Day 7Incidence of fever within 7 days after surgery
Postoperative respiratory infectionPostoperative Day 7Incidence of respiratory infection within 7 days after surgery
Composite outcome of major postoperative complicationsPostoperative Day 3Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 3 days after surgery
Postoperative urinary system infectionPostoperative Day 7Incidence of urinary system infection within 7 days after surgery
Postoperative colitis or infection with Clostridium difficilePostoperative Day 7Incidence of colitis or infection with Clostridium difficile within 7
Postoperative endometritisPostoperative Day 7Incidence of endometritis within 7 days after surgery
Postoperative surgical site infectionPostoperative Day 7Incidence of surgical site infection within 7 days after surgery
Postoperative deep incisional surgical site infectionPostoperative Day 7Incidence of deep incisional surgical site infection within 7 days after surgery
Postoperative organ or space surgical site infectionPostoperative Day 7Incidence of organ or space surgical site infection within 7 days after surgery
Postoperative unknown infection with pathogenic organisms in tissue or fluidPostoperative Day 7Incidence of unknown infection with pathogenic organisms in tissue or fluid
Postoperative sepsisPostoperative Day 7Incidence of sepsis within 7 days after surgery
Hospital dischargePostoperative Day 90Time-to-event outcome with the event hospital discharge
Unplanned hospital re-admissionPostoperative Day 30Incidence of unplanned hospital re-admission within 30 days after surgery
Postoperative neurological infectionPostoperative Day 7Incidence of neurological infection within 7 days after surgery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026