An observational study in Systemic Inflammatory Response Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
Intervention Six ml of blood will be sampled at Day 0 (beginning of the SIRS), D1, D3, D7. Concentrations of candidate proteins will be determined in the plasma by ELISA, and the link between each concentration and each outcome analyzed.
Additionally, broncho-alveolar lavage will be analyzed in the same way, if performed for the routine care of the patient.
The link between plasma and alveolar levels of each protein and each outcome will be evaluated, using Mann-Whitney U-test and one-way ANOVA for categorical variables (for example comparison of protein X plasma level between survivors or nonsurvivors at 30 days), and Pearson's correlation for continuous variables (for example link between protein X plasma level and daily fluid balance at each time point).
Sample size calculation. Plasma and pulmonary concentrations of each protein that we will study have never been described during SIRS. Based on our first screening cohort patients with severe capillary leakage had a difference in VEGF plasma concentration of 15.5 pg/ml, with a standard deviation of 32 pg/ml. Basing the calculation on this parameter, with an alpha risk of 5% and a power of 90%, a sample size of 180 patients would provide 90% chances to find a statistical link between one protein concentration and the outcomes of the patients.
180 studies on the registry are indexed under Systemic Inflammatory Response Syndrome; 24 are open to participants now.
This study's planned enrollment of 180 is above the median of 134 across 88 observational studies indexed under Systemic Inflammatory Response Syndrome.
Browse Systemic Inflammatory Response Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Adult patients admitted in the European Georges Pompidou Hospital or La Pitié-Salpêtrière ICU, and exhibiting a systemic inflammatory response syndrome (SIRS)
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:
Exclusion Criteria:
6 ml blood sampling at Day 0, 1, 3, 7. Broncho-alveolar sampling, if performed in routine care.
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,...)
Time frame: Between Day 0 and Day 3
Fluid balance (ml/kg of initial body weight).
The fluid balance, routinely monitored in ICU, represents fluid intakes (perfusion, oral intakes,..) - fluid losses (diuresis, diarrhea,...)
Time frame: Day 1, Day 3, Day 7
Extra-vascular lung water index
Extra-vascular lung water index (EVLWi, ml/kg) and pulmonary vascular permeability index measured by transpulmonary thermodilution at corresponding time-points
Time frame: Day 0, Day 1, Day 3, Day 7
SOFA score
Association between circulating candidate proteins, the immune-inflammatory profile of the patients and SOFA score (Sepsis-related Organ Failure Assessment), score values between 0-24, higher scores mean a worse outcome
Time frame: Day 0, Day 1, Day 3, Day 7,
Serum albuminemia
Serum albuminemia in g/L
Time frame: Day 0, Day 1, Day 3, Day 7,
Catecholamine-free days
Number of days alive without receiving any catecholamine
Time frame: Day 0, Day 1, Day 3, Day 7, Day 30
Ventilatory-free days
Number of days alive without receiving any mechanical ventilation, invasive or non-invasive
Time frame: Day 0, Day 1, Day 3, Day 7, Day 30
Renal replacement therapy-free Number of days alive without receiving any renal replacement therapy
Number of days alive without receiving any renal replacement therapy
Time frame: Day 0, Day 1, Day 3, Day 7, Day 30
Mortality
Time frame: Day 30
Plan to share: Yes — All deidentified individual participant data collected for our study "SIRS-PERM" will be shared beginning with publication with no end date. These data will be available to researchers to who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to the corresponding author via email: nicolas.brechot@aphp.fr and will be reviewed by the senior authors of the study. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.
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