Evidence map›Paper›PMID 34980224›Full record

ArticleTrials2022

Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial.

Armand Mekontso Dessap, François Bagate, Clément Delmas, Tristan Morichau-Beauchant, Bernard Cholley, Alain Cariou, Benoit Lattuca, Mouhamed Moussa, Nicolas Mongardon, Damien Fard and 11 more

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

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03773822 (Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.5field-weighted citation impact, top 20% 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.

NCT03773822 phase3completednot on this map

Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study

TypeinterventionalSponsorCMC Ambroise ParéRan2019 to 2023Enrolled380ConditionsCardiogenic ShockArmsHydrocortisone + Flucortac, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Observational
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. The medical treatment of cardiogenic shock.Journal of intensive medicine · 2023
    Review
  13. 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

21 authors at 13 institutions in 1 country.

Armand Mekontso Dessap *Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation, F-94010, Créteil, France. armand.dessap@aphp.fr.
François Bagate *Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri-Mondor, Service de Médecine Intensive Réanimation, F-94010, Créteil, France.ORCID http://orcid.org/0000-0002-3391-0807
Clément DelmasIntensive Cardiac Care Unit, Rangueil University Hospital, Toulouse, France.
Tristan Morichau-BeauchantCentre Cardiologique du Nord, service de réanimation, St Denis, France.
Bernard CholleyAP-HP, Hôpital Européen Georges Pompidou, Service d'Anesthésie-Réanimation, Paris, France.
Alain CariouAP-HP, Centre-Université de Paris, Hôpital Cochin, Service de Médecine Intensive Réanimation, Paris, France.
Benoit LattucaHôpital Universitaire de Nîmes, Unité de soins Intensifs cardiologique, Nîmes, France.
Mouhamed MoussaCHU de Lille, Service d'Anesthésie-Réanimation cardiovasculaire, Lille, France.
Nicolas MongardonU955-IMRB, Equipe 03 "Pharmacologie et Technologies pour les Maladies Cardiovasculaires (PROTECT)", Inserm, Univ Paris Est Créteil (UPEC), Ecole Nationale Vétérinaire d'Alfort (EnVA), F-94700, Maisons-Alfort, France.
Damien FardAP-HP, Hôpitaux Universitaires Henri-Mondor, Unité de soins Intensifs cardiologique, F-94010, Créteil, France.
Matthieu SchmidtAP-HP, Hôpital Pitié-Salpétrière, Service de Médecine Intensive Réanimation, Paris, France.
Adrien BougléAP-HP, Hôpital Pitié-Salpétrière, Service d'Anesthésie-Réanimation cardiovasculaire, Paris, France.
Mathieu KerneisAP-HP, Hôpital Pitié-Salpétrière, Unité de soins Intensifs cardiologique, Paris, France.
Emmanuel VivierCentre Hospitalier Saint Joseph Saint Luc, Service de Médecine Intensive Réanimation, Lyon, France.
François RoubillePhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, INI-CRT, Montpellier, France.
Matthieu DupreyGrand Hôpital de l'Est Francilien, Hôpital Jossigny, Service de Médecine Intensive Réanimation, Marne la Vallée, France.
Véronique DecalfCentre Hospitalier de Pontoise, Unité de soins Intensifs cardiologique, Pontoise, France.
Thibaud GenetCHU de Tours, Unité de soins Intensifs cardiologique, Tours, France.
Messaouda MerzougCMC Ambroise Paré, département de recherche clinique, Neuilly-sur-Seine, France.
Etienne AudureauAP-HP, Hôpitaux Universitaires Henri-Mondor, Service de recherche clinique, F-94010, Créteil, France.
Pierre SquaraCMC Ambroise Paré, département de recherche clinique, Neuilly-sur-Seine, France.
Assistance Publique – Hôpitaux de Paris · FRInserm · FRClinique Ambroise Paré · FRSorbonne Université · FRCentre Cardiologique du Nord · FRCentre Hospitalier René-Dubos · FRCentre Hospitalier Saint-Joseph Saint-Luc · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Nîmes · FRCentre Hospitalier Universitaire de Tours · FRCentre National de la Recherche Scientifique · FRHôpital Rangueil · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiogenic shock (CS) is a life-threatening condition characterized by circulatory insufficiency caused by an acute dysfunction of the heart pump. The pathophysiological approach to CS has recently been enriched by the tissue consequences of low flow, including inflammation, endothelial dysfunction, and alteration of the hypothalamic-pituitary-adrenal axis. The aim of the present trial is to evaluate the impact of early low-dose corticosteroid therapy on shock reversal in adults with CS. METHOD/

designThis is a multicentered randomized, double-blind, placebo-controlled trial with two parallel arms in adult patients with CS recruited from medical, cardiac, and polyvalent intensive care units (ICU) in France. Patients will be randomly allocated into the treatment or control group (1:1 ratio), and we will recruit 380 patients (190 per group). For the treatment group, hydrocortisone (50 mg intravenous bolus every 6 h) and fludrocortisone (50 μg once a day enterally) will be administered for 7 days or until discharge from the ICU. The primary endpoint is catecholamine-free days at day 7. Secondary endpoints include morbidity and all-cause mortality at 28 and 90 days post-randomization. Pre-defined subgroups analyses are planned, including: postcardiotomy, myocardial infarction, etomidate use, vasopressor use, and adrenal profiles according the short corticotropin stimulation test. Each patient will be followed for 90 days. All analyses will be conducted on an intention-to-treat basis. DISCUSSION: This trial will provide valuable evidence about the effectiveness of low dose of corticosteroid therapy for CS. If effective, this therapy might improve outcome and become a therapeutic adjunct for patients with CS.

trial registrationClinicalTrials.gov , NCT03773822 . Registered on 12 December 2018.

Indexed as

COVID-19Shock, CardiogenicAdultHumansHypothalamo-Hypophyseal SystemMulticenter Studies as TopicPituitary-Adrenal SystemRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeAdrenal insufficiencyCardiogenic shockCorticosteroidFludrocortisoneHydrocortisone

Identifiers

PMID34980224
PMCPMC8722083
OpenAlexW4205551532

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.