Perioperative Personalized Blood Pressure Management: IMPROVE-multi (IMPROVE)
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ClinicalTrials.gov Identifier: NCT05416944 |
Recruitment Status :
Active, not recruiting
First Posted : June 14, 2022
Last Update Posted : April 30, 2024
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Condition or disease | Intervention/treatment | Phase |
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Blood Pressure Intraoperative Hypotension Postoperative Complications Surgery Anesthesia | Other: Personalized blood pressure management | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual 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 : | May 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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
- 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
- Postoperative acute kidney injury [ Time Frame: Postoperative Day 3 ]Incidence of acute kidney injury within 3 days after surgery
- Postoperative acute kidney injury [ Time Frame: Postoperative Day 7 ]Incidence of acute kidney injury within 7 days after surgery
- 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
- 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
- Postoperative non-fatal cardiac arrest [ Time Frame: Postoperative Day 3 ]Incidence of non-fatal cardiac arrest within 3 days after surgery
- Postoperative non-fatal cardiac arrest [ Time Frame: Postoperative Day 7 ]Incidence of non-fatal cardiac arrest within 7 days after surgery
- Postoperative death [ Time Frame: Postoperative Day 3 ]Incidence of death within 3 days after surgery
- Postoperative death [ Time Frame: Postoperative Day 7 ]Incidence of death within 7 days after surgery
- 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
- 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
- Postoperative need for renal replacement therapy [ Time Frame: Postoperative Day 30 ]Incidence of need for renal replacement therapy within 30 days after surgery
- Postoperative need for renal replacement therapy [ Time Frame: Postoperative Day 90 ]Incidence of need for renal replacement therapy within 90 days after surgery
- Postoperative myocardial infarction [ Time Frame: Postoperative Day 30 ]Incidence of myocardial infarction within 30 days after surgery
- Postoperative myocardial infarction [ Time Frame: Postoperative Day 90 ]Incidence of myocardial infarction within 90 days after surgery
- Postoperative non-fatal cardiac arrest [ Time Frame: Postoperative Day 30 ]Incidence of non-fatal cardiac arrest within 30 days after surgery
- Postoperative non-fatal cardiac arrest [ Time Frame: Postoperative Day 90 ]Incidence of non-fatal cardiac arrest within 90 days after surgery
- Postoperative death [ Time Frame: Postoperative Day 30 ]Incidence of death within 30 days after surgery
- Postoperative death [ Time Frame: Postoperative Day 90 ]Incidence of death within 90 days after surgery
- 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
- Postoperative fever [ Time Frame: Postoperative Day 7 ]Incidence of fever within 7 days after surgery
- Postoperative respiratory infection [ Time Frame: Postoperative Day 7 ]Incidence of respiratory infection within 7 days after surgery
- Postoperative neurological infection [ Time Frame: Postoperative Day 7 ]Incidence of neurological infection within 7 days after surgery
- Postoperative urinary system infection [ Time Frame: Postoperative Day 7 ]Incidence of urinary system infection within 7 days after surgery
- Postoperative colitis or infection with Clostridium difficile [ Time Frame: Postoperative Day 7 ]Incidence of colitis or infection with Clostridium difficile within 7
- Postoperative endometritis [ Time Frame: Postoperative Day 7 ]Incidence of endometritis within 7 days after surgery
- Postoperative surgical site infection [ Time Frame: Postoperative Day 7 ]Incidence of surgical site infection within 7 days after surgery
- Postoperative deep incisional surgical site infection [ Time Frame: Postoperative Day 7 ]Incidence of deep incisional surgical site infection within 7 days after surgery
- 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
- 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
- Postoperative sepsis [ Time Frame: Postoperative Day 7 ]Incidence of sepsis within 7 days after surgery
- Hospital discharge [ Time Frame: Postoperative Day 90 ]Time-to-event outcome with the event "hospital discharge"
- Unplanned hospital re-admission [ Time Frame: Postoperative Day 30 ]Incidence of unplanned hospital re-admission within 30 days after surgery
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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
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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
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
Germany | |
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf | |
Hamburg, Germany, 20246 |
Principal Investigator: | Bernd Saugel, M.D. | Department of Anesthesiology, University Medical Center Hamburg-Eppendorf |
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: | April 30, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypotension Postoperative Complications Vascular Diseases Cardiovascular Diseases Pathologic Processes |