Management of Angiotensin Inhibitors During the Perioperative Period

Summary

This is a multicenter randomized clinical trial to determine the effect of continuation versus withdrawal of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the perioperative period on postoperative complications.

Conditions

• Surgery
• Angiotensin Hypertension
• Perioperative Complication

Interventions

DRUG

Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers

Withdrawal from 24 hours before surgery until 24-48 hours after surgery. The ACEI/ARB medication is resumed on the second or third day after surgery, as soon as the clinical condition allows based on judgement by the attending physician.

DIAGNOSTIC_TEST

Blood draw

Blood will be drawn to measure creatinin and troponin: once before surgery, on the first and second postoperative day, and within 4-8 weeks after surgery

BEHAVIORAL

Diary to register drug adherence

To register medication adherence, patients will be asked to fill out their medication intake (of ACEI/ARB) in a diary from a week before surgery until surgery.

BEHAVIORAL

Quality of life questionnaire

Patients are asked to fill out a quality of life questionnaire (EQ-5D) before surgery and at three months after surgery

BEHAVIORAL

WHODAS questionnaire

Patients are asked to fill out a questionnaire about disabilities (WHO Disability Assessment Schedule 2.0) before surgery and at three months after surgery

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Principal Investigators

• Judith van Waes, MD PhD · UMC Utrecht

• Wilton van Klei, MD PhD · UMC Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-11

Primary Completion

2023-02-06

Completion

2023-09-01

Countries

• Canada
• Netherlands

Study Locations