Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2023-12-24

Brief Summary

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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.

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Detailed Description

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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 will be performed by the anesthesiologist Control group : RAS-I discontinuation Experimental group: RAS-I continuation
* A prescription for the medication strategy (stopping or pursuing the medication) will be handed to the patient during the anesthesiology consultation.

Five follow-up visits are planned

* Immediately, one hour after the surgery (Day 0)
* Then four follow-up visits are planned on day 1, 2, 7 (or hospital discharge) and 28 days+15 days (43 days maximum) after surgery will be collected data and parameters for study endpoints.

End of research visit is the 28 days+15 days (43 days maximum) follow-up visit.

Conditions

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Renin Angiotensin System Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The aim of this study is to evaluate the impact of Renin-Angiotensin System inhibitors management (Continuation or discontinuation 48 hours before surgery) on outcome in patients undergoing scheduled 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)

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Endpoint validated by an adjudication commitee blinded to the arm.

Study Groups

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continuation of the RAS-inhibitors

in the continuation of the RAS-inhibitors arm the treatment will be continued until the morning the day of surgery.

Group Type EXPERIMENTAL

continuation of the RAS-inhibitors

Intervention Type PROCEDURE

drug intake

discontinuation of the RAS-inhibitors

In this arm : discontinuation of the RAS-inhibitors 48 hours before surgery Patients won't receive the drug on the morning of the day of the surgery.

Group Type ACTIVE_COMPARATOR

discontinuation of the RAS-inhibitors

Intervention Type PROCEDURE

no drug intake

Interventions

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continuation of the RAS-inhibitors

drug intake

Intervention Type PROCEDURE

discontinuation of the RAS-inhibitors

no drug intake

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No