Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy: A Randomized Clinical Trial
Primary result · Mean daily SOFA scoreResult — go to the resultAdjusted mean difference 0.2 95% CI −0.8 to 1.2- Trial stopped for futility at the planned interim analysis
Authors' conclusion
In this randomized clinical trial of adults in the ICU with septic shock and severe endotheliopathy, infusion of iloprost, 1 ng/kg/min, for 72 hours did not reduce mean daily SOFA scores compared with placebo.
Study context
- Population
- Adults in the intensive care unit (ICU) with septic shock and endotheliopathy (plasma soluble thrombomodulin >10 ng/mL), 6 hospitals in Denmark278 analysed
- Participants
- 279 adults
- Comparison
- Iloprost 1 ng/kg/min IV for 72 hours vs placebo
- Iloprostn = 142
- Placebon = 137reference
- Primary endpoint
- Mean daily Sequential Organ Failure Assessment (SOFA) score in the ICU, adjusted for trial site and baseline SOFA score, per-protocol population
Methodological detailsinvestigator-initiated, adaptive, parallel group, stratified, double-blind, multicentre (6 hospitals), interim analysis for futility
- Investigator-initiated
- Adaptive
- Parallel group
- Stratified
- Double-blind
- Multicentre (6 hospitals)
- Interim analysis for futility
Primary result
Mean daily SOFA score
Adjusted mean difference
0.2
95% CI −0.8 to 1.2
P = 0.70
By group
Iloprost
10.6
mean · IQR 6.4–14.8
Placebo
10.5
mean · IQR 5.9–15.5
Iloprost vs Placebo
adjusted mean difference 0.2 (95% CI −0.8 to 1.2); P = 0.70
As reported in the abstract
Secondary outcomes
| Outcome | Iloprost | Placebo | Adjusted RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Mortality · 90 days | 57% | 51% | 1.12 (0.91–1.40) | P = 0.33 | |
| 0.512Adjusted relative risk (log scale) |
Safety
| Outcome | Iloprost | Placebo | Adjusted RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious adverse events · 7 days | 18% | 15% | 1.25 (0.73–2.15) | P = 0.52 | |
| 0.512Adjusted relative risk (log scale) |
Serious adverse reactions · 7 days
- Only 1 serious adverse reaction observed
Original publication
Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy: A Randomized Clinical Trial. JAMA Netw Open. Published 3 September 2024. doi:10.
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