Status:
COMPLETED
Perioperative Personalized Blood Pressure Management: IMPROVE-multi
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Jena University Hospital
The Cleveland Clinic
Conditions:
Blood Pressure
Intraoperative Hypotension
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT05416944
Start Date
February 26 2023
End Date
July 25 2024
Last Update
December 11 2024
Active Locations (1)
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1
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246