CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,222 enrolled
Drug / intervention
continuation of the RAS-inhibitors +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03374449
NCT03374449N/ACompleted

Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery : a Multicenter, Prospective, Randomized and Controlled Trial

Assistance Publique - Hôpitaux de Paris·interventional·Posted Dec 15, 2017·Updated May 22, 2024

In Brief

A clinical study evaluating continuation of the RAS-inhibitors and discontinuation of the RAS-inhibitors for Renin Angiotensin System and Surgery. Completed, enrolled 2,222 participants across 1 site.

Detailed 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 hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications. The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 15, 2017
Enrollment StartFeb 6, 2018
Primary CompletionDec 24, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 8.5 years ago

Interventions

continuation of the RAS-inhibitorsprocedure

drug intake

discontinuation of the RAS-inhibitorsprocedure

no drug intake