Management of Angiotensin Inhibitors During the Perioperative Period

NCT04506372 | Terminated DMC

• 1 other identifier: AIPOP
• Study Type: interventional
• Target: 342
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Noncardiac surgery; Angiotensin inhibitors; Perioperative management

Outcome Measures

Primary Outcomes (1)

• Postoperative acute kidney injury

  Postoperative acute kidney injury, defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guideline.

  Within two days after surgery

Secondary Outcomes (14)

• Postoperative myocardial injury

  Within two days after surgery

• Acute postoperative myocardial injury

  Within two days after surgery

• Intraoperative hypotension

  From the start of anesthesia until the end of surgery

• Postoperative hypotension

  From the end of surgery up to and including the second postoperative day

• Preoperative hypertension

  Within 24 hours before start of anesthesia

Study Arms (2)

Intervention group

EXPERIMENTAL

Perioperative withdrawal of ACEI/ARB.

Drug: Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers; Diagnostic Test: Blood draw; Behavioral: Diary to register drug adherence; Behavioral: Quality of life questionnaire; Behavioral: WHODAS questionnaire

Control group

ACTIVE COMPARATOR

Perioperative continuation of ACEI/ARB.

Diagnostic Test: Blood draw; Behavioral: Diary to register drug adherence; Behavioral: Quality of life questionnaire; Behavioral: WHODAS questionnaire

Interventions

Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers DRUG

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.

Intervention group

Blood draw DIAGNOSTIC_TEST

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

Control group; Intervention group

Diary to register drug adherence BEHAVIORAL

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.

Control group; Intervention group

Quality of life questionnaire BEHAVIORAL

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

Control group; Intervention group

WHODAS questionnaire BEHAVIORAL

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic ACEI or ARB use for the treatment of hypertension. Patients who use a com-bination pill with a diuretic are eligible as well;
• Scheduled for elective intermediate to high risk noncardiac surgery, defined according to the European Society of Cardiology / European Society of Anesthesiology guidelines on noncardiac surgery;
• Expected postoperative length of stay of at least two days.

You may not qualify if:

• Severe chronic kidney disease, defined as GFR\<30 ml/min/1.73 m2;
• ACEI/ARB use for the treatment of chronic systolic heart failure, defined as left ven-tricular ejection fraction ≤40%;
• ACEI/ARB use within one year after ST-elevated myocardial infarction, according to the fourth universal definition of myocardial infarction;
• Transplant surgery;
• ACEI/ARB use in a combination pill together with a drug other than a diuretic, including calcium channel blockers, beta-blockers and neprilysin inhibitors;
• Use of drugs acting on the renin-angiotensin-aldosterone system other than ACEI/ARB, e.g. aliskiren.

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

University Health Network Toronto

Toronto, Ontorio, Canada

Location

Amsterdam UMC location AMC

Amsterdam, Netherlands

Location

Amsterdam UMC location VU

Amsterdam, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Antonius Hospital

Nieuwegein, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Judith van Waes, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Wilton van Klei, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.A.R. van Waes, MD PhD

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 11, 2020
• Primary Completion: February 6, 2023
• Study Completion: September 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CA (1); NL (6)