Stopping blood pressure medications before 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.
PHASE3 · Kasr El Aini Hospital · NCT06862115
This study is testing whether stopping certain blood pressure medications before colorectal cancer surgery can help prevent heart injury in adults undergoing the procedure.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06862115 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of discontinuing renin-angiotensin system (RAS) inhibitors on myocardial injury in adult patients undergoing major abdominal surgeries for colorectal cancer. It is a prospective, open-label, randomized controlled trial where participants will be randomly assigned to either continue or stop their RAS inhibitors prior to surgery. The study will measure myocardial injury through troponin-I levels, with investigators blinded to the primary outcome measure. The trial will follow participants from the preoperative visit until 24 hours post-surgery to assess the effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with chronic hypertension controlled on RAS inhibitors, scheduled for major abdominal cancer surgery.
Not a fit: Patients who have had a recent myocardial infarction, require emergency surgery, or have conditions that would be worsened by stopping their medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the safest approach to managing blood pressure medications in patients undergoing major surgeries, potentially reducing the risk of myocardial injury.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored the effects of RAS inhibitors in surgical settings, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Cairo university hospitals — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Khaled Sarhan, MD
- Email: khaled.sarhan@kasralainy.edu.eg
- Phone: +201020067816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardium, Injury, Perioperative/Postoperative Complications, Angiotensin-Converting-Enzyme Inhibitor