Skip to main content
OpenTrials
Completed

NCT Number: NCT05416944

Perioperative Personalized Blood Pressure Management: IMPROVE-multi

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Pressure Anesthesia Intraoperative Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite outcome of major postoperative complications

    Time frame: Postoperative Day 7

    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

Secondary outcomes

  1. Composite outcome of major postoperative complications

    Time frame: Postoperative Day 3

    Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 3 days after surgery

  2. Postoperative acute kidney injury

    Time frame: Postoperative Day 3

    Incidence of acute kidney injury within 3 days after surgery

  3. Postoperative acute kidney injury

    Time frame: Postoperative Day 7

    Incidence of acute kidney injury within 7 days after surgery

  4. Postoperative acute myocardial injury (including myocardial infarction)

    Time frame: Postoperative Day 3

    Incidence of acute myocardial injury (including myocardial infarction) within 3 days after surgery

  5. Postoperative acute myocardial injury (including myocardial infarction)

    Time frame: Postoperative Day 7

    Incidence of acute myocardial injury (including myocardial infarction) within 7 days after surgery

  6. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 3

    Incidence of non-fatal cardiac arrest within 3 days after surgery

  7. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 7

    Incidence of non-fatal cardiac arrest within 7 days after surgery

  8. Postoperative death

    Time frame: Postoperative Day 3

    Incidence of death within 3 days after surgery

  9. Postoperative death

    Time frame: Postoperative Day 7

    Incidence of death within 7 days after surgery

  10. Composite outcome of long-term postoperative complications

    Time frame: Postoperative Day 30

    Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery

  11. Composite outcome of long-term postoperative complications

    Time frame: Postoperative Day 90

    Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery

  12. Postoperative need for renal replacement therapy

    Time frame: Postoperative Day 30

    Incidence of need for renal replacement therapy within 30 days after surgery

  13. Postoperative need for renal replacement therapy

    Time frame: Postoperative Day 90

    Incidence of need for renal replacement therapy within 90 days after surgery

  14. Postoperative myocardial infarction

    Time frame: Postoperative Day 30

    Incidence of myocardial infarction within 30 days after surgery

  15. Postoperative myocardial infarction

    Time frame: Postoperative Day 90

    Incidence of myocardial infarction within 90 days after surgery

  16. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 30

    Incidence of non-fatal cardiac arrest within 30 days after surgery

  17. Postoperative non-fatal cardiac arrest

    Time frame: Postoperative Day 90

    Incidence of non-fatal cardiac arrest within 90 days after surgery

  18. Postoperative death

    Time frame: Postoperative Day 30

    Incidence of death within 30 days after surgery

  19. Postoperative death

    Time frame: Postoperative Day 90

    Incidence of death within 90 days after surgery

  20. Postoperative infectious complications

    Time frame: Postoperative Day 7

    Collapsed 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

  21. Postoperative fever

    Time frame: Postoperative Day 7

    Incidence of fever within 7 days after surgery

  22. Postoperative respiratory infection

    Time frame: Postoperative Day 7

    Incidence of respiratory infection within 7 days after surgery

  23. Postoperative neurological infection

    Time frame: Postoperative Day 7

    Incidence of neurological infection within 7 days after surgery

  24. Postoperative urinary system infection

    Time frame: Postoperative Day 7

    Incidence of urinary system infection within 7 days after surgery

  25. Postoperative colitis or infection with Clostridium difficile

    Time frame: Postoperative Day 7

    Incidence of colitis or infection with Clostridium difficile within 7

  26. Postoperative endometritis

    Time frame: Postoperative Day 7

    Incidence of endometritis within 7 days after surgery

  27. Postoperative surgical site infection

    Time frame: Postoperative Day 7

    Incidence of surgical site infection within 7 days after surgery

  28. Postoperative deep incisional surgical site infection

    Time frame: Postoperative Day 7

    Incidence of deep incisional surgical site infection within 7 days after surgery

  29. Postoperative organ or space surgical site infection

    Time frame: Postoperative Day 7

    Incidence of organ or space surgical site infection within 7 days after surgery

  30. Postoperative unknown infection with pathogenic organisms in tissue or fluid

    Time frame: Postoperative Day 7

    Incidence of unknown infection with pathogenic organisms in tissue or fluid

  31. Postoperative sepsis

    Time frame: Postoperative Day 7

    Incidence of sepsis within 7 days after surgery

  32. Hospital discharge

    Time frame: Postoperative Day 90

    Time-to-event outcome with the event "hospital discharge"

  33. Unplanned hospital re-admission

    Time frame: Postoperative Day 30

    Incidence of unplanned hospital re-admission within 30 days after surgery

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Jena University Hospital
  • The Cleveland Clinic

Registry information

Official study title

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

Acronym: IMPROVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.