Determinants of Vascular Leakage During Systemic Inflammatory Response Syndrome

NCT05663216 | Recruiting

• 1 other identifier: APHP220418
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND Controlling vascular leakage, which is independently associated with mortality during Sepsis and cardiogenic shock, may be a promising approach during systemic inflammatory response syndrome (SIRS). During a collaborative work between La Pitié-Salpêtrière intensive care unit (ICU) and the unit INSERM U1050 (National Institute oh Health and medical Research), we identified 38 genes associated with capillary leakage during systemic inflammation response syndrome (SIRS) in humans. The aim of this study is to evaluate their possible implication in vascular hyperpermeability associated with METHODS SIRS-PERM is a prospective multicenter cohort study, testing the correlation between the plasma and broncho-alveolar levels of proteins isolated from our first screening, and the level of vascular leakage during SIRS. All patients admitted in the European Georges-Pompidou or La Pitié-Salpêtrière ICU and presenting a SIRS will be eligible for inclusion. Plasma samples will be collected at day 0, D1, D3 and D7, as well as broncho-alveolar lavage samples if clinically indicated. Concentration of each protein will be determined by ELISA in those samples. A statistical association will be then tested between each protein concentration and, for each time-point, the level of capillary leakage (daily weight and fluid balance, extra-vascular lung water index and pulmonary permeability index measured by transpulmonary thermodilution), and ARDS (acute respiratory distress syndrome) severity (PaO2/FiO2 ratio, Murray score and pulmonary compliance). Its link with hemodynamic status, the level of multiple organ failure, and vital status at day 30, will be also assessed. Basing the calculation of the sample size on the variations of VEGF (Vascular endothelial growth factor) expression in our first screening cohort, we calculated a sample size of 180 patients for this study, for a total duration of the study of 5 years. IMPLICATIONS: SIRS-PERM will assess the determinants of capillary leakage during SIRS. It may thus provide a better understanding of the pathophysiology of this disease, with the goal to isolate new markers of severity, as well as new therapeutic targets to treat it. Modulating specifically capillary leakage is indeed a totally new approach during this pathology.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

Systemic inflammatory response syndrome; Vascular leakage; Capillary leakage; fluid balance

Outcome Measures

Primary Outcomes (1)

• Fluid balance from Day 0 to day 3 (ml/kg of initial body weight).

  The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,...)

  Between Day 0 and Day 3

Secondary Outcomes (8)

• Fluid balance (ml/kg of initial body weight).

  Day 1, Day 3, Day 7

• Extra-vascular lung water index

  Day 0, Day 1, Day 3, Day 7

• SOFA score

  Day 0, Day 1, Day 3, Day 7,

• Serum albuminemia

  Day 0, Day 1, Day 3, Day 7,

• Catecholamine-free days

  Day 0, Day 1, Day 3, Day 7, Day 30

Interventions

Blood sampling OTHER

6 ml blood sampling at Day 0, 1, 3, 7. Broncho-alveolar sampling, if performed in routine care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted in the European Georges Pompidou Hospital or La Pitié-Salpêtrière ICU, and exhibiting a systemic inflammatory response syndrome (SIRS)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Adult Medical-Surgical Intensive Care Unit, Necker Hospital of the Sick Children

Paris, 75015, France

RECRUITING

Medical Intensive Care Unit, Georges Pompidou European Hospital

Paris, 75015, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Six ml of blood will be sampled at Day 0 (beginning of the SIRS), D1, D3, D7

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nicolas Brechot, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Brechot, MD,PhD

CONTACT

1-56-09-23-42; nicolas.brechot@aphp.fr

Emmanuelle Guérin, MD

CONTACT

1-56-09-32-04; emmanuelle.guerin@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: May 31, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (2)