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Perioperative Personalized Blood Pressure Management: IMPROVE-multi (IMPROVE)

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ClinicalTrials.gov Identifier: NCT05416944
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : July 5, 2023
Sponsor:
Collaborators:
Jena University Hospital
The Cleveland Clinic
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Intraoperative Hypotension Postoperative Complications Surgery Anesthesia Other: Personalized blood pressure management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 26, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05416944


Contacts
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Contact: Bernd Saugel, M.D. 004940741052415 b.saugel@uke.de
Contact: Karim Kouz, M.D. 004940741052415 k.kouz@uke.de

Locations
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Germany
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Karim Kouz, Dr    +49 40 7410 52415    k.kouz@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Jena University Hospital
The Cleveland Clinic
Investigators
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Principal Investigator: Bernd Saugel, M.D. Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT05416944    
Other Study ID Numbers: ZKSJ0147
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Postoperative Complications
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes