drugset / Trial / NCT01669434

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

NCT01669434 ↗

Phase 4 Completed 291 enrolled University of Nebraska
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively. Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Timeline

Start
2015-06-01
Primary completion
2016-11-01
Completion
2016-12-01

Outcome

Met primary endpoint

paper Intraoperative hypotension occurred less frequently in the omission group (76 of 137 [55%]) than in the continuation group (95 of 138 [69%]) PMID 30261084 ↗

registry analysis (superiority test); ACEI Omission vs ACEI Continuation; p = 0.03; Risk Ratio (RR) 0.81 (95% CI 0.67 to 0.97); Fisher Exact NCT01669434 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Benazepril Unknown — —
Subject Captopril Small molecule — —
Subject Enalapril Other / unclassified — —
Subject Fosinopril Small molecule — —
Subject LISINOPRIL ANHYDROUS Small molecule — —
Subject Moexipril Small molecule — —
Subject Perindopril Small molecule — —
Subject Quinapril Small molecule — —
Subject Ramipril Small molecule — —
Subject trandolapril Small molecule — —

Indications

No indication recorded.