Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery
Condition: Renin Angiotensin System; Surgery
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): continuation of the RAS-inhibitors; discontinuation of the RAS-inhibitors
Intervention type(s): Procedure; Procedure
Intervention description(s): drug intake; no drug intake
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Major surgery; Postoperative morbidity and mortality; Renin angiotensin system inhibitors