The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery

NCT ID: NCT06862115

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-01-01

Brief Summary

The aim of this study is to estimate the effect of discontinuation of RAS inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries.

Detailed Description

This is a prospective, open-label, randomized controlled non inferiority trial. Participants will be assigned randomly in a 1:1 manner whether to stop or continue RAS inhibitors. Randomization will be performed using an online program (www.randomizer.com).

Trial participants and staff will not be blinded to treatment group allocation however, all investigators will be blinded to the primary outcome measure (myocardial injury).

After randomization during the preoperative visit, participants will be instructed to stop or continue their ACE-I and/or ARB according to their allocated group. ACE-I and/or ARB will be continued or discontinued as per treatment group allocation and this will continue until 24 hours after the end of surgery. Since ACE-I and ARB have different durations of action, participants will receive drug-specific instructions as to when to stop. When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery. Renin-angiotensin system inhibitors will be restarted after surgery on the morning of post-operative day one if systolic blood pressure was >120 mmHg in the previous 12 hours.

The anesthetic induction, intraoperative and postoperative management will be managed according to the local policy of the NCI by expert anesthesiologists who will be blinded to the patients' groups.

Troponin-I will be measured at 9 a.m. on the day before surgery and at 9 a.m. on postoperative day one and day two. Myocardial injury will be defined as: (Troponin-I an increase by 0.015 is considered positive, if the baseline is <0.05 A. If the baseline is higher than 0.05, an increase by 0.005 is considered positive).

Conditions

Myocardium; Injury; Perioperative/Postoperative Complications; Angiotensin-Converting-Enzyme Inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

stop RAS

When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.

Group Type: EXPERIMENTAL

ACE-I and/or ARB antihypertensive treatment

Intervention Type: DRUG

When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.

continue RAS

ACE-I and ARBs will be continued till morning of surgery

Group Type: ACTIVE_COMPARATOR

ACE-I and/or ARB antihypertensive treatment

Intervention Type: DRUG

When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.

Interventions

ACE-I and/or ARB antihypertensive treatment

When the ACE-I and/or ARB duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. All other ACE-I and/or ARB will be stopped 24 hours before surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Both sexes
• ASA 2-3
• Chronic hypertensive patients (> 3 months before surgery) controlled on ACEIs or ARBs or combination therapy containing one of the RAS inhibitors.
• Scheduled for major abdominal cancer surgery (surgery with an expected duration of > 2 h from the surgical incision and a postoperative hospital stay of least three days).

Exclusion Criteria

• Patient refusal.
• Recent myocardial infarction (within 3 months).
• Any condition, which in the opinion of the treating clinician, would result in the patient being harmed by the cessation of the ACE-I and/or ARB therapy.
• Emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Khaled Sarhan, MD

Role: CONTACT

khaled.sarhan@kasralainy.edu.eg

+201020067816

Facility Contacts

Khaled Sarhan, MD

Role: primary

khaled.sarhan@kasralainy.edu.eg

+201020067816

Other Identifiers

MS-525-2024

Identifier Type: -

Identifier Source: org_study_id