Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial
Primary result · Change in SOFA scoreResult — go to the resultMedian difference 1 95% CI 0–3Authors' conclusion
Among patients with septic shock and persistent hypoperfusion, iloprost did not reduce the severity of organ failure.
Study context
- Population
- Adults with septic shock and persistent hypoperfusion (increased capillary refill time and/or skin mottling)236 analysed
- Participants
- 240 adults
- Comparison
- 48-h IV iloprost infusion vs placebo
- Primary endpoint
- Change in Sequential Organ Failure Assessment (SOFA) score from randomisation to Day 7
- Follow-up
- Day 7
Methodological detailsmulticentre, double-blind, placebo-controlled
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
Change in SOFA score
Median difference
1
95% CI 0–3
P = 0.12
Change by group
Iloprost
−4
median · IQR −7–7
Placebo
−5
median · IQR −8–5
Iloprost vs Placebo
median difference 1 (95% CI 0–3); P = 0.12
As reported in the abstract
Secondary outcomes
| Outcome | Iloprost | Placebo | RR (95% CI) | |
|---|---|---|---|---|
| Mortality · 28 days | 42% | 39% | 1.08 (0.80–1.5) | |
| 0.512Relative risk (log scale) |
Median
| Outcome | Iloprost | Placebo | Median difference (95% CI) | |
|---|---|---|---|---|
| Mean daily (average) SOFA score | 11.2 (IQR 7.4–15.9) | 10.5 (IQR 6.8–16.5) | 0.25 (−1.1 to 1.8) | |
| −2−1012Difference (linear scale) |
| Outcome | Median difference (days) (95% CI) | |
|---|---|---|
| Ventilation-free survival days · 28 days | 0 (0–0) | |
| Vasopressor-free survival days · 28 days | 0 (−1 to 1) | |
| RRT-free survival days · 28 days | 0 (0–0) | |
| −1.5−1−0.500.511.5Difference, days (linear scale) |
Safety
Severe adverse events
P = 0.06
Original publication
Iloprost for the Treatment of Severe Septic Shock with Persistent Hypoperfusion: A Double-Blind, Randomized Controlled Trial. Am J Respir Crit Care Med. Published 1 July 2025. doi:10.
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