Understanding factors causing vascular leakage in systemic inflammatory response syndrome
Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome
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 |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05663216 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults admitted to the ICU with a diagnosis of systemic inflammatory response syndrome.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.