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

NCT06862115 | Recruiting Phase 3

• 1 other identifier: MS-525-2024
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Highest level of Troponin-I measured within 48 hours of surgery.

  48 hours

• Incidence of perioperative hypotension

  48 hours

• Incidence of severe hypotension

  48 hours

• Incidence of perioperative severe hypertension

  48 hours

Study Arms (2)

stop RAS

EXPERIMENTAL

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

continue RAS

ACTIVE COMPARATOR

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

Drug: ACE-I and/or ARB antihypertensive treatment

Interventions

ACE-I and/or ARB antihypertensive treatment 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; stop RAS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Khaled Sarhan, MD

CONTACT

+201020067816; khaled.sarhan@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Asst. professor of anesthesia, Cairo university

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

EG (1)