IMMUNOCITRE
Trial question
What is the role of enteral citrulline supplementation in mechanically ventilated ICU patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 120
120 patients (44 female, 76 male).
Inclusion criteria: critically ill adult patients under invasive mechanical ventilation without sepsis or septic shock.
Key exclusion criteria: BMI > 40 kg/m²; immunocompromised state; contraindication to enteral nutrition; surgery within one month prior to enrollment; pregnancy; sepsis or septic shock.
Interventions
N=60 L-citrulline (at a dose of 5 g every 12 hours for 5 days).
N=60 placebo (standard isonitrogenous or isocaloric placebo for 5 days).
Primary outcome
Sequential Organ Failure Assessment score at day 7
4 points
4 points
4.0 points
3.0 points
2.0 points
1.0 points
0.0 points
L-citrulline
Placebo
Borderline significant
increase ▲
Borderline significant increase in SOFA score at day 7 (4 points vs. 4 points).
Secondary outcomes
No significant difference in improvement in SOFA score by day 7 (58.3% vs. 63.3%; RR 0.92, 95% CI -4.05 to 5.89).
No significant difference in nosocomial infections acquisition (13.3% vs. 28.3%; RR 0.47, 95% CI -0.22 to 1.16).
No significant difference in median ICU length of stay to discharge or death (9 days vs. 11 days; AD -2 days, 95% CI -4.38 to 0.38).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In critically ill adult patients under invasive mechanical ventilation without sepsis or septic shock, L-citrulline was not superior to placebo with respect to SOFA score at day 7.
Reference
Jean-Marc Tadié, Clara Locher, Adel Maamar et al. Enteral citrulline supplementation versus placebo on SOFA score on day 7 in mechanically ventilated critically ill patients: the IMMUNOCITRE randomized clinical trial. Crit Care. 2023 Oct 3;27(1):381.
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