Phase 4 N=291 Randomized Treatment

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

Hypotension on Induction

Bottom Line

View on ClinicalTrials.gov: NCT01669434 ↗

Enrolled (actual)

291

Serious AEs

1.8%

Results posted

Dec 2017

Primary outcome: Primary: Number of Participants With Interoperative Hypotension — 76; 95 Participants — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: ACEI continuation (Drug); ACEI omission (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Nov 2016

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

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01669434). 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.