Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

NCT ID: NCT01669434

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-12-01

Brief 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.

Detailed 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.

Conditions

Hypotension on Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACEI continuation

Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively

Group Type: EXPERIMENTAL

ACEI continuation

Intervention Type: DRUG

These chronic medications will be taken without interruption preoperatively.

ACEI omission

Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.

Group Type: EXPERIMENTAL

ACEI omission

Intervention Type: DRUG

Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.

Interventions

ACEI continuation

These chronic medications will be taken without interruption preoperatively.

Intervention Type: DRUG

ACEI omission

Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.

Intervention Type: DRUG

Other Intervention Names

quinapril; Accupril; perindopril; Aceon; ramipril; Altace; benazepril; Lotensin; captopril; Capoten; enalapril; Vasotec; fosinopril; Monopril; lisinopril; Prinivil; Zestril; trandolapril; Mavik; moexipril; Univasc; quinapril; Accupril; perindopril; Aceon; ramipril; Altace; benazepril; Lotensin; captopril; Capoten; enalapril; Vasotec; fosinopril; Monopril; lisinopril; Prinivil; Zestril; trandolapril; Mavik; moexipril; Univasc

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 < 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason F Shiffermiller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

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Other Identifiers

0369-12-FB

Identifier Type: -

Identifier Source: org_study_id