Understanding factors causing vascular leakage in systemic inflammatory response syndrome
Official title: Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome
Run by Assistance Publique - Hôpitaux de Paris · NCT05663216 · Data updated 2026-11-12
This study is trying to see if certain proteins in the blood are linked to leaks in blood vessels in patients with systemic inflammatory response syndrome to help improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Status | Recruiting |
| Started | May 31, 2023 |
| Main results expected | July 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT05663216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults admitted to the ICU with a diagnosis of systemic inflammatory response syndrome.
✕Probably not a fit
Patients under 18 years old, pregnant women, or those with severe comorbidities such as advanced cirrhosis or nephrotic syndrome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the relationship between specific proteins and vascular leakage in patients experiencing systemic inflammatory response syndrome (SIRS). Conducted in collaboration between two intensive care units in Paris, the study will collect blood samples from patients at various time points to analyze protein concentrations. The goal is to identify genetic determinants that may contribute to vascular hyperpermeability during SIRS, which is critical for improving patient outcomes in severe cases.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for patients with SIRS, potentially reducing mortality associated with vascular leakage.
How similar studies have gone: While this approach is novel in the context of SIRS, previous studies have shown the importance of vascular leakage in sepsis and related conditions, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients admitted in the European Georges Pompidou Hospital or La Pitié-Salpêtrière ICU, and exhibiting a systemic inflammatory response syndrome (SIRS), characterized by the following items: * Temperature \> 38°C ou \<36°C * Heart rate \>90/min * Respiratory rate \>20/min or PaCO2\<32mmHg * White cell count \> 12 000/mm3 ou \< 4 000/mm3 Exclusion Criteria: * Age \<18 years * Decline to participate * Pregnancy * Cirrhosis Child-Pugh \> B * Denutrition with BMI\<15kg/m2 * Nephrotic syndrome * Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)
Where it's running
-
Adult Medical-Surgical Intensive Care Unit, Necker Hospital of the Sick Children
Paris, France Recruiting -
Medical Intensive Care Unit, Georges Pompidou European Hospital
Paris, France Recruiting
Study contacts
- Principal investigator: Nicolas Brechot, MD,PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Nicolas Brechot, MD,PhD
- Email: nicolas.brechot@aphp.fr
- Phone: 1-56-09-23-42
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.