Evidence map›Paper›PMID 34098992›Full record

ArticleTrials2021

Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study.

Heather A Smith, Salmaan Kanji, Diem T T Tran, Calum Redpath, Dean Ferguson, Tori Lenet, Greg Sigler, Sebastien Gilbert, Donna Maziak, Patrick Villeneuve and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04392921 (Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04392921 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2022 to 2024Enrolled80ConditionsAtrial FibrillationArmsAmiodarone, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Heather A Smith *Division of General Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada. hsmit037@uottawa.ca.ORCID http://orcid.org/0000-0002-7736-4641
Salmaan Kanji *Department of Pharmacy, The Ottawa Hospital and Ottawa Hospital Research Institute, Ottawa, Canada.
Diem T T TranDivision of Cardiac Anesthesiology, Department of Anesthesiology & Pain Medicine, University of Ottawa Heart Institute, Ottawa, Canada.
Calum RedpathUniversity of Ottawa Heart Institute, Ottawa, Canada.
Dean FergusonOttawa Hospital Research Institute, Ottawa, Canada.
Tori LenetDivision of General Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Greg SiglerDivision of General Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Sebastien GilbertDivision of Thoracic Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Donna MaziakDivision of Thoracic Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Patrick VilleneuveDivision of Thoracic Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Sudhir SundaresanDivision of Thoracic Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
Andrew J E Seely *Division of Thoracic Surgery, Department of Surgery, University of Ottawa, Ottawa, Canada.
University of Ottawa · CAOttawa Hospital · CA

Funding

The Ottawa Hospital Academic Medicine Organization (CA) TOH -21 -014
6 · The paper itself

Abstract

backgroundPostoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic amiodarone, which is only recommended in high-risk individuals due to the potential associated side effects. Risk factors for POAF have been identified and incorporated into a prediction model to identify high-risk patients. Further evaluation in the form of a multicenter clinical trial is required to assess the effectiveness of prophylaxis specifically in this high-risk population. The feasibility of such a trial first needs to be assessed.

methodsThe PREP-AF trial is a double-blind randomized controlled feasibility trial. Individuals undergoing major thoracic surgery who are identified to be high-risk by the POAF prediction model will be randomized 1:1 to receive a short course of amiodarone vs. placebo in the immediate postoperative period. The primary outcome is feasibility, which will be measured by the number of eligible patients identified, consented, and randomized; intervention adherence; and measurement of future outcomes of a full trial. DISCUSSION: This study will determine the feasibility of a randomized controlled trial to assess the effectiveness of prophylactic amiodarone, in high-risk patients undergoing major thoracic surgery. This will inform the development of a multi-center trial to establish if prophylactic amiodarone is safe and effective at reducing the incidence of POAF. Preventing this adverse event will not only improve outcomes for patients but also reduce the associated health resource utilization and costs.

trial registrationClinicalTrials.gov NCT04392921 . Registered on 19 May 2020.

Indexed as

AmiodaroneAtrial FibrillationAnti-Arrhythmia AgentsFeasibility StudiesHumansMulticenter Studies as TopicPostoperative ComplicationsPostoperative PeriodRandomized Controlled Trials as TopicAmiodaroneAnti-Arrhythmia AgentsArrhythmiaPostoperative atrial fibrillationPreventionProphylaxisThoracic surgery

Identifiers

PMID34098992
PMCPMC8182941
OpenAlexW3171183048

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.