Status:
COMPLETED
Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Renin Angiotensin System
Surgery
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertensi...
Detailed Description
Multicenter, prospective, randomized, pragmatic, parallel-group clinical trial. The inclusion visit takes place between 4 months and no later than 3 days before the surgery visit. * The randomization...
Eligibility Criteria
Inclusion
- Patients requiring major non-cardiac surgery (surgery with an expected duration of more than 2 hours from the surgical incision and a post-operative hospital stay of least 3 days) (according to the study RELIEF, DOI : 10.1056/NEJMoa1801601))
- Age≥18 years
- Patients chronically treated (\>3 months before surgery) with RAS inhibitors
- Pregnancy test at inclusion visit for women of childbearing potential Women of childbearing potential must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG)
- Signed informed consent
Exclusion
- Emergency surgery (surgical treatment needed within 24 hours)
- Hyperkalemia (\> 5.5mmol/L) known at the time of the anesthetic consultation
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 1 month
- Patient with severe renal insufficiency, known at the time of the anesthestic consultation (as defined by estimated glomerular filtration rate (creatinine clearance \<15 ml/min/1.73m2 or requiring renal replacement therapy)
- Patient with preoperative shock (defined by the need for vasoactive drugs before surgery)
- Inability to obtain informed consent either from the patient.
- Lack of Social Insurance
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2023
Estimated Enrollment :
2222 Patients enrolled
Trial Details
Trial ID
NCT03374449
Start Date
February 6 2018
End Date
December 24 2023
Last Update
May 22 2024
Active Locations (1)
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1
Hospital Lariboisiere
Paris, France, 75010