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

The Effect of Discontinuation of Renin Angiotensin System Inhibitors on the Perioperative Myocardial Injury in Adult Patients Undergoing Colorectal Cancer Surgery: a Randomized Controlled Non Inferiority Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Perioperative/Postoperative Complications; Myocardium; Injury; Angiotensin-Converting-Enzyme Inhibitor
• Intervention / Treatment: Drug: ACE-I and/or ARB antihypertensive treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Khaled Sarhan, MD; Phone Number: +201020067816; Email: khaled.sarhan@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals
    • Contact: Khaled Sarhan, MD; Phone Number: +201020067816; Email: khaled.sarhan@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: continue RAS; ACE-I and ARBs will be continued till morning of surgery	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is the incidence of myocardial injury 48 hours after surgery	defined as: (Troponin-I If the baseline is <0.05 And increase by 0.015 is considered positive If the baseline is higher than 0.05, an increase by 0.005 is considered positive	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest level of Troponin-I measured within 48 hours of surgery.	Highest level of Troponin-T measured within 48 hours of surgery.	48 hours
Incidence of perioperative hypotension	Incidence of perioperative hypotension (MAP<20% of baseline measure recorded night before surgery) until 48 hours after surgery.	48 hours
Incidence of severe hypotension	Incidence of severe hypotension (MAP < 60 mmHg requiring any vasopressor) until 48 hours after surgery.	48 hours
Incidence of perioperative severe hypertension	Incidence of perioperative severe hypertension (BP>180/100mmHg) until 48 hours after surgery.	48 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Postoperative Complications; Antihypertensive Agents
• Other Study ID Numbers: MS-525-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No