Phase 4
Completed N=291
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Hypotension on Induction
Source: ClinicalTrials.gov NCT01669434 ↗
Enrolled (actual)
291
Serious AEs
1.8%
Results posted
Dec 2017
Primary outcomePrimary: Number of Participants With Interoperative Hypotension — 76; 95 Participants — p=0.03
◆ Published Evidence
Established
63citations · ~8 / year
Prospective Randomized Evaluation of Preoperative Angiotensin-Converting Enzyme Inhibition (PREOP-ACEI).
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.
Linked Publications
-
Prospective Randomized Evaluation of Preoperative Angiotensin-Converting Enzyme Inhibition (PREOP-ACEI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Interoperative Hypotension |
76; 95 | 0.03 sig |
| SECONDARY Acute Renal Failure |
6; 10 | 0.44 |
| SECONDARY Low Blood Pressure Subgroup |
4; 2 | 1.0 |
| SECONDARY Older Age Subgroup |
48; 49 | 1.0 |
| SECONDARY Postoperative Hypertension |
33; 17 | 0.01 sig |
| SECONDARY Postoperative Hypotension |
15; 31 | 0.02 sig |
Eligibility Criteria
Inclusion Criteria
- Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation.
- Above referral must be in anticipation of a non-cardiac, non-vascular surgery.
- Must have been on ACE-Inhibitor therapy for at least six weeks.
Exclusion Criteria
- Hypotension (systolic blood pressure 150 or diastolic blood pressure > 95) at the time of preoperative evaluation
- Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology)
- Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)
- Left Ventricular ejection fraction less than 40%
- Clinical evidence of decompensated heart failure at the time of preoperative evaluation
- End-stage renal disease
- Organ transplant surgeries
Data sourced from ClinicalTrials.gov (NCT01669434) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.