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Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial).
- Source :
-
Trials [Trials] 2019 Mar 05; Vol. 20 (1), pp. 160. Date of Electronic Publication: 2019 Mar 05. - Publication Year :
- 2019
-
Abstract
- Background: Chronic treatment of hypertension or heart failure very often includes an angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin receptor blockers (ARBs) as renin-angiotensin system inhibitors (RASi) treatments. To stop or not to stop these medications before major surgery remains an unresolved issue. The lack of evidence leads to conflicting guidelines with respect to RASi management before major surgery. The purpose of this study is to evaluate the impact of a strategy of RASi continuation or discontinuation on perioperative complications in patients undergoing major non-cardiac surgery.<br />Methods: This is a multicenter, open-labeled randomized controlled trial in > 30 French centers. In the experimental group, RASi will be continued while the treatment will be stopped 48 h before the surgery in the control arm. The primary endpoint is a composite endpoint of major complications after surgery. An endpoint adjudication committee will review clinical data and adjudicate efficacy endpoints while blinded to the assigned study drug group. Main analysis will be by intention-to-treat comparing the composite outcome measure at 28 days in the two groups. A total of 2222 patients are planned to detect an absolute complications difference of 5%.<br />Discussion: The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery.<br />Trial Registration: ClinicalTrials.gov, NCT03374449 . Registered on 11 December 2017.
- Subjects :
- Angiotensin Receptor Antagonists adverse effects
Angiotensin-Converting Enzyme Inhibitors adverse effects
Drug Administration Schedule
France
Heart Failure diagnosis
Heart Failure physiopathology
Humans
Hypertension diagnosis
Hypertension physiopathology
Multicenter Studies as Topic
Perioperative Care adverse effects
Postoperative Complications etiology
Randomized Controlled Trials as Topic
Risk Factors
Time Factors
Treatment Outcome
Angiotensin Receptor Antagonists administration & dosage
Angiotensin-Converting Enzyme Inhibitors administration & dosage
Heart Failure drug therapy
Hypertension drug therapy
Perioperative Care methods
Renin-Angiotensin System drug effects
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 20
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 30836981
- Full Text :
- https://doi.org/10.1186/s13063-019-3247-1