Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial
- Type de publi. : Article dans une revue
- Date de publi. : 01/07/2025
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Auteurs :
Matthieu LegrandEdouard JullienAntoine KimmounGuillaume GeriHafid Ait-OufellaStanislas AbrardSamuel GaugainFanny BounesPhilippe GuerciJulien PottecherMatthieu JammeYves Poncelin de RaucourtDamien BarraudJean-Michel ConstantinWilliam JuguetSigismond LasockiRomain SonnevilleJuliette AudibertGaëtan PlantefèveOlivier EllrodtAnne-Laure FedouMarc LeoneLaurent LefebvreAdrien AuvetDavid ChenEric VicautFrançois Dépret
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Organismes :
University of California [San Francisco]
Investigation Network Initiative - Cardiovascular and Rénal Clinical Trialist
Hôpital Ambroise Paré [AP-HP]
Université de Versailles Saint-Quentin-en-Yvelines
Investigation Network Initiative - Cardiovascular and Rénal Clinical Trialist
Défaillance Cardiovasculaire Aiguë et Chronique
French-Clinical Research Infrastructure Network - F-CRIN [Paris]
Clinique Ambroise Paré [Centres Médico-Chirurgicaux Ambroise Paré, Pierre Cherest, Hartmann]
CHU Saint-Antoine [AP-HP]
Hôpital Edouard Herriot [CHU - HCL]
Hôpital Lariboisière-Fernand-Widal [APHP]
Centre Hospitalier Universitaire de Toulouse
Investigation Network Initiative - Cardiovascular and Rénal Clinical Trialist
Centre Hospitalier Régional Universitaire de Nancy
Défaillance Cardiovasculaire Aiguë et Chronique
Centre Hospitalier Universitaire [Strasbourg]
Ramsay Santé
Centre Hospitalier de Bourg en Bresse
Centre hospitalier régional de Metz-Thionville
CHU Pitié-Salpêtrière [AP-HP]
Hôpital Avicenne [AP-HP]
Centre Hospitalier Universitaire d'Angers
Infection, Anti-microbiens, Modélisation, Evolution
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Hôpitaux de Chartres [Chartres]
Centre hospitalier Victor Dupouy [Centre hospitalier d'Argenteuil]
Centre Hospitalier de Melun
Centre Hospitalier Universitaire Dupuytren 1 et 2
Hôpital Nord [CHU - APHM]
Centre Hospitalier d'Aix en Provence [Aix-en-Provence]
Centre Hospitalier Dax - Côte d'Argent
University of California [San Francisco]
Investigation Network Initiative - Cardiovascular and Rénal Clinical Trialist
Hôpital Lariboisière-Fernand-Widal [APHP]
Marqueurs cardiovasculaires en situation de stress
Investigation Network Initiative - Cardiovascular and Rénal Clinical Trialist
Assistance publique - Hôpitaux de Paris (AP-HP)
- Publié dans American Journal of Respiratory and Critical Care Medicine le 26/10/2020
Résumé : Rationale: Preclinical and preliminary clinical data suggest that iloprost may improve tissue perfusion in septic shock. However, its effect on organ failure remains unclear. Objectives: To investigate whether iloprost provides organ protection in septic shock with hypoperfusion. Methods: In this multicenter, double-blind, randomized controlled trial, adults with septic shock and persistent hypoperfusion (i.e., increased capillary refill time and/or skin mottling) were randomized to receive a 48-hour intravenous infusion of iloprost or placebo. The primary outcome was the change in the Sequential Organ Failure Assessment (SOFA) score from randomization to Day 7. Secondary outcomes included mortality at Day 28, organ support-free days by Day 28, and mean daily SOFA score. Measurements and Main Results: A total of 240 patients were randomized, and 236 were included in the analysis. Median (IQR) changes in SOFA score were -4 (-7 to 7) in the iloprost group and -5 (-8 to 5) in the placebo group (median difference, 1; 95% CI, 0-3; P = 0.12). At 28 days, 48 patients (42%) had died in the iloprost group and 47 (39%) had died in the placebo group (relative risk, 1.08; 95% CI, 0.80-1.5). The median average SOFA score was 11.2 (7.4-15.9) in the iloprost group, compared with 10.5 (6.8-16.5) in the placebo group (median difference, 0.25; 95% CI, -1.1 to 1.8). Median (95% confidence interval) between-group differences in 28-day ventilation-, vasopressor-, and renal replacement therapy-free survival days were 0 (0-0), 0 (-1 to 1), and 0 (0-0), respectively. Severe adverse events occurred in 15% of patients in the iloprost group and 7% of patients in the placebo group (P = 0.06). Conclusions: Among patients with septic shock and persistent hypoperfusion, iloprost did not reduce the severity of organ failure. Clinical trial registered with www.clinicaltrials.gov (NCT03788837) and EudraCT (2018-001709-10).
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