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).
Angiotensin Receptor Antagonists
/ administration & dosage
Angiotensin-Converting Enzyme Inhibitors
/ administration & dosage
Drug Administration Schedule
France
Heart Failure
/ diagnosis
Humans
Hypertension
/ diagnosis
Multicenter Studies as Topic
Perioperative Care
/ adverse effects
Postoperative Complications
/ etiology
Randomized Controlled Trials as Topic
Renin-Angiotensin System
/ drug effects
Risk Factors
Time Factors
Treatment Outcome
ACE inhibitors
ARB
Acute kidney injury
Complications
Mortality
Outcome
Strategy
Surgery
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 Mar 2019
05 Mar 2019
Historique:
received:
18
07
2018
accepted:
12
02
2019
entrez:
7
3
2019
pubmed:
7
3
2019
medline:
18
7
2019
Statut:
epublish
Résumé
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. 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%. The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery. ClinicalTrials.gov, NCT03374449 . Registered on 11 December 2017.
Sections du résumé
BACKGROUND
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.
METHODS
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%.
DISCUSSION
CONCLUSIONS
The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03374449 . Registered on 11 December 2017.
Identifiants
pubmed: 30836981
doi: 10.1186/s13063-019-3247-1
pii: 10.1186/s13063-019-3247-1
pmc: PMC6402139
doi:
Substances chimiques
Angiotensin Receptor Antagonists
0
Angiotensin-Converting Enzyme Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT03374449']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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