Evidence map›Paper›PMID 30115103›Full record

Trial reportCritical care (London, England)2018

Intravenous ivabradine versus placebo in patients with low cardiac output syndrome treated by dobutamine after elective coronary artery bypass surgery: a phase 2 exploratory randomized controlled trial.

Lee S Nguyen, Pierre Squara, Julien Amour, Daniel Carbognani, Kamel Bouabdallah, Stéphane Thierry, Caroline Apert-Verneuil, Aurélie Moyne, Bernard Cholley

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
1.9field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  10. Observational
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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

9 authors at 6 institutions in 1 country.

Lee S NguyenCritical Care Medicine, CMC Ambroise Paré, Neuilly-sur-Seine, France.
Pierre SquaraCritical Care Medicine, CMC Ambroise Paré, Neuilly-sur-Seine, France.
Julien AmourAnesthesiology and Critical Care Medicine, Hôpital de la Pitié-Salpétrière, AP-HP, and Université Pierre et Marie Curie, Paris, France.
Daniel CarbognaniAnesthesiology and Critical Care Medicine, Institut Mutualiste Monsouris, Paris, France.
Kamel BouabdallahAnesthesiology and Critical Care Medicine, Institut Mutualiste Monsouris, Paris, France.
Stéphane ThierryAnesthesiology and Critical Care Medicine, Centre Cardiologique du Nord, Saint-Denis, France.
Caroline Apert-VerneuilInstitut de Recherches Internationales Servier, Suresnes, France.
Aurélie MoyneInstitut de Recherches Internationales Servier, Suresnes, France.
Bernard CholleyAnesthesiology and Critical Care Medicine Department, Hôpital Européen Georges Pompidou, AP-HP, and Université Paris Descartes-Sorbonne Paris Cité, Paris, France. bernard.cholley@aphp.fr.
Institute Mutualiste Montsouris · FRServier (France) · FRSorbonne Université · FRAssistance Publique – Hôpitaux de Paris · FRCentre Cardiologique du Nord · FRDélégation Paris 5 · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLow cardiac output syndrome (LCOS) is a severe condition which can occur after cardiac surgery, especially among patients with pre-existing left ventricular dysfunction. Dobutamine, its first-line treatment, is associated with sinus tachycardia. This study aims to assess the ability of intravenous ivabradine to decrease sinus tachycardia associated with dobutamine infused for LCOS after coronary artery bypass graft (CABG) surgery.

methodsIn a phase 2, multi-center, single-blind, randomized controlled trial, patients with left ventricular ejection fraction below 40% presenting sinus tachycardia of at least 100 beats per minute (bpm) following dobutamine infusion for LCOS after CABG surgery received either intravenous ivabradine or placebo (three ivabradine for one placebo). Treatment lasted until dobutamine weaning or up to 48 h. The primary endpoint was the proportion of patients achieving a heart rate (HR) in the 80- to 90-bpm range. Secondary endpoints were invasive and non-invasive hemodynamic parameters and arrhythmia events.

resultsNineteen patients were included. More patients reached the primary endpoint in the ivabradine than in the placebo group (13 (93%) versus 2 (40%); P = 0.04). Median times to reach target HR were 1.0 h in the ivabradine group and 5.7 h in the placebo group. Ivabradine decreased HR (112 to 86 bpm, P <0.001) while increasing cardiac index (P = 0.02), stroke volume (P <0.001), and systolic blood pressure (P = 0.03). In the placebo group, these parameters remained unchanged from baseline. In the ivabradine group, five patients (36%) developed atrial fibrillation (AF) and one (7%) was discontinued for sustained AF; two (14%) were discontinued for bradycardia.

conclusionIntravenous ivabradine achieved effective and rapid correction of sinus tachycardia in patients who received dobutamine for LCOS after CABG surgery. Simultaneously, stroke volume and systolic blood pressure increased, suggesting a beneficial effect of this treatment on tissue perfusion.

trial registrationEuropean Clinical Trials Database: EudraCT 2009-018175-14 . Registered February 2, 2010.

Indexed as

Administration, IntravenousAgedCardiac Output, LowCardiotonic AgentsCardiovascular AgentsCoronary Artery BypassDobutamineElective Surgical ProceduresFemaleHumansIvabradineMaleMiddle AgedPlacebosSingle-Blind MethodCardiotonic AgentsCardiovascular AgentsDobutamineIvabradinePlacebosCardiac surgeryCardiogenic shockCoronary artery bypass graftDobutamineLow cardiac output syndromePostoperative atrial fibrillationSinus tachycardiaSystolic heart failure

Identifiers

PMID30115103
PMCPMC6097391
OpenAlexW2885427980

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.