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)
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 surg...
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| Format: | Article |
| Language: | English |
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BMC
2019-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3247-1 |
| _version_ | 1818278887436582912 |
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| author | Matthieu Legrand Emmanuel Futier Marc Leone Benjamin Deniau Alexandre Mebazaa Benoît Plaud Pierre Coriat Patrick Rossignol Eric Vicaut Etienne Gayat for the STOP-OR-NOT study investigators |
| author_facet | Matthieu Legrand Emmanuel Futier Marc Leone Benjamin Deniau Alexandre Mebazaa Benoît Plaud Pierre Coriat Patrick Rossignol Eric Vicaut Etienne Gayat for the STOP-OR-NOT study investigators |
| author_sort | Matthieu Legrand |
| collection | DOAJ |
| description | 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. 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 The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery. Trial registration ClinicalTrials.gov, NCT03374449. Registered on 11 December 2017. |
| first_indexed | 2024-12-12T23:24:34Z |
| format | Article |
| id | doaj.art-66e5540b3df842fcb40a8d7da2c2be96 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T23:24:34Z |
| publishDate | 2019-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-66e5540b3df842fcb40a8d7da2c2be962022-12-22T00:08:09ZengBMCTrials1745-62152019-03-012011710.1186/s13063-019-3247-1Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)Matthieu Legrand0Emmanuel Futier1Marc Leone2Benjamin Deniau3Alexandre Mebazaa4Benoît Plaud5Pierre Coriat6Patrick Rossignol7Eric Vicaut8Etienne Gayat9for the STOP-OR-NOT study investigatorsAP-HP, GH St-Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, St-Louis Hospital, Assistance Publique-Hopitaux de ParisDépartement de Médecine Périopératoire, Anesthésie Réanimation Hôpital Estaing, CHU Clermont-Ferrand & Université Clermont Auvergne, CNRS, InsermService d’Anesthésie et de Réanimation, Hôpital Nord, Aix Marseille Université, APHMAP-HP, GH St-Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, St-Louis Hospital, Assistance Publique-Hopitaux de ParisAP-HP, GH St-Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, St-Louis Hospital, Assistance Publique-Hopitaux de ParisAP-HP, GH St-Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, St-Louis Hospital, Assistance Publique-Hopitaux de ParisDépartement d’Anesthésie-Réanimation, La Pité-Salpétrière, Université Paris DescartesF-CRIN INI-CRCT networkUnité de recherche Clinique, GH St-Louis-Lariboisère-Fernand Widal, Université Paris DiderotAP-HP, GH St-Louis-Lariboisière, Department of Anesthesiology and Critical Care and Burn Unit, St-Louis Hospital, Assistance Publique-Hopitaux de ParisAbstract 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 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 The results of the trial should provide robust evidence to anesthesiologists and surgeons regarding management of RASi before major non-cardiac surgery. Trial registration ClinicalTrials.gov, NCT03374449. Registered on 11 December 2017.http://link.springer.com/article/10.1186/s13063-019-3247-1ACE inhibitorsARBStrategyOutcomeComplicationsAcute kidney injury |
| spellingShingle | Matthieu Legrand Emmanuel Futier Marc Leone Benjamin Deniau Alexandre Mebazaa Benoît Plaud Pierre Coriat Patrick Rossignol Eric Vicaut Etienne Gayat for the STOP-OR-NOT study investigators 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) Trials ACE inhibitors ARB Strategy Outcome Complications Acute kidney injury |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | ACE inhibitors ARB Strategy Outcome Complications Acute kidney injury |
| url | http://link.springer.com/article/10.1186/s13063-019-3247-1 |
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