Evidence map›Paper›PMID 32611377›Full record

ArticleTrials2020

The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial.

Matthieu Legrand, Hafid Ait Oufella, Daniel De Backer, Jacques Duranteau, Marc Leone, Bruno Levy, Patrick Rossignol, Eric Vicaut, François Dépret, I-MICRO trial investigators

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

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03788837 (" ILOPROST for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT03788837 phase3completednot on this map

" ILOPROST for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial:The I-MICRO Trial

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2019 to 2024Enrolled240ConditionsSeptic Shock HyperdynamicArmsILOPROST, NaCl
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Iloprost for the treatment of frostbite: a scoping review.International journal of circumpolar health · 2023
    Article
  7. Microcirculation and Mitochondria: The Critical Unit.Journal of clinical medicine · 2023
    Review
  8. Review
  9. Review
  10. Overcoming barriers in the design and implementation of clinical trials for acute kidney injury: a report from the 2020 Kidney Disease Clinical Trialists meeting.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Review
  11. Review
  12. 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

10 authors at 7 institutions in 3 countries.

Matthieu LegrandDepartment of Anaesthesiology, Critical Care Medicine and Burn Unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 2 rue A. Paré, 75010, Paris, France. Matthieu.legrand@ucsf.edu.ORCID http://orcid.org/0000-0001-9788-5316
Hafid Ait OufellaAssistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, 75571, Paris Cedex 12, France.
Daniel De BackerIntensive Care Department, CHIREC Hospitals, Université Libre de Bruxelles, Brussels, Belgium.
Jacques DuranteauDepartment of Anesthesia and Intensive Care, Hôpitaux Universitaires Paris Sud, Université Paris Sud XI, Le Kremlin Bicêtre, France.
Marc LeoneAix Marseille Université, Assistance Publique Hôpitaux de Marseille, Service d'Anesthésie et de Réanimation, Hôpital Nord, Marseille, France.
Bruno LevyService de Réanimation Médicale, Centre Hospitalo-Universitaire de Nancy, F-54511, Vandœuvre-Lès-Nancy, France.
Patrick RossignolCentre d'Investigation Clinique Plurithématique Pierre Drouin-INSERM CHU de Nancy, Nancy, France.
Eric VicautAPHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, Paris, France.
François DépretDepartment of Anaesthesiology, Critical Care Medicine and Burn Unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 2 rue A. Paré, 75010, Paris, France.
I-MICRO trial investigators
Inserm · FRAssistance Publique Hôpitaux de Marseille · FRUniversité Libre de Bruxelles · BECentre Hospitalier Régional et Universitaire de Nancy · FRDélégation Paris 7 · FRSorbonne Université · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeptic shock remains a significant cause of death in critically ill patients. During septic shock, some patients will retain microcirculatory disorders despite optimal hemodynamic support (i.e., fluid resuscitation, vasopressors, inotropes). Alterations in the microcirculation are a key pathophysiological factor of organ dysfunction and death in septic shock patients. Ilomedin is a prostacyclin analog with vasodilatory effect and anti-thrombotic properties (i.e., inhibition of platelet aggregation) preferentially at the microcirculatory level. We hypothesize that early utilization of intravenous Ilomedin in septic shock patients with clinical persistence of microperfusion disorders would improve the recovery of organ dysfunction.

methodsThe I-MICRO trial is a multicenter, prospective, randomized, double-blinded, placebo-controlled study. We plan to recruit 236 adult patients with septic shock and persistent microcirculatory disorders (i.e., skin mottling or increased capillary refill time) despite hemodynamic support. Participants will be randomized to receive a 48-h intravenous infusion of either Ilomedin or placebo starting at the earliest 6 h and later 24 h after septic shock. The primary outcome will be the change (delta) of sequential organ failure assessment (SOFA) score between randomization and day 7. Secondary outcomes will include mean SOFA score during the first 7 days after randomization, mortality at day 28 post-randomization, number of ventilation-free survival days in the 28 days post-randomization, number of renal replacement therapy-free survival days in the 28 days post-randomization, number of vasopressor-free survival days in the 28 days post-randomization, and mottling score at day 1 after randomization. DISCUSSION: The trial aims to provide evidence on the efficacy and safety of Ilomedin in patients with septic shock and persistent microcirculatory disorders.

trial registrationNCT NCT03788837 . Registered on 28 December 2018.

Indexed as

Clinical Trials, Phase III as TopicDouble-Blind MethodFranceHemodynamicsHumansIloprostInfusions, IntravenousMicrocirculationMulticenter Studies as TopicOrgan Dysfunction ScoresProspective StudiesRandomized Controlled Trials as TopicShock, SepticTreatment OutcomeVasodilator AgentsIloprostVasodilator AgentsCapillary refill timeIloprostMicrocirculationOutcomeProstacyclinSepsisSkin mottlingVasodilator

Identifiers

PMID32611377
PMCPMC7329442
OpenAlexW3038362975

What OpenQuestion holds

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LicenceCC BY
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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.