Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

University of Nebraska

Status and phase

Completed

Phase 4

Conditions

Hypotension on Induction

Treatments

Drug: ACEI omission

Drug: ACEI continuation

Study type

Interventional

Funder types

Other

Identifiers

NCT01669434

0369-12-FB

Details and patient eligibility

About

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.

Full description

The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.

Enrollment

291 patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

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 < 90 or diastolic blood pressure <60) at the time of preoperative evaluation
Uncontrolled Hypertension (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