Clinical trial NCT03641690: Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome
Official title: Evolution of Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome (ARDS) Without or With Extracorporeal Mechanical Assistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H1N1 Influenza
Keywords: pandemic influenza
mortality
ICU
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient according to the present invention, has self optimized by a medical report: sedation, curarization, protective ventilation and adapted PEEP, under and without treatment with BAL and blood samples on the dry tube and EDTA in its care can be included in our study.

At the time of the diagnosis of ARDS, and during the aetiological assessment, one can highlight a blood sample, samples of tubes for the assays of the inflammation.

Brief summary: Mannose-binding lectin (MBL) plays an important role in the innate immune response. In addition to activating the complement, MBL can induce cytokine production and contribute to a deleterious inflammatory response with severe A(H1N1)pdm09 virus infection. The aim was to determine if serum MBL levels correlate with the risk of mortality in intensive care units (ICU) patients with A(H1N1)pdm09 infection.

Prospective observational study was performed in ICU patients with acute respiratory distress syndrome due to influenza A(H1N1)pdm09 virus. Demographic characteristics and severity indices were recorded at ICU admission. MBL was assayed from blood drawn at influenza diagnosis within 24-48 h following the ICU admission. Outcomes were compared according to MBL levels.

Detailed description: Mannose-binding lectin (MBL) plays an important role in the innate immune response. In addition to activating the complement, MBL can induce cytokine production and contribute to a deleterious inflammatory response with severe A(H1N1)pdm09 virus infection. The aim was to determine if serum MBL levels correlate with the risk of mortality in intensive care units (ICU) patients with A(H1N1)pdm09 infection.

Prospective observational study was performed in ICU patients with acute respiratory distress syndrome due to influenza A(H1N1)pdm09 virus. Demographic and clinical data at admission and during the ICU stay were recorded from the medical files of each patient and collected in a database to evaluate variables potentially associated with in-hospital mortality. Data baselines were recorded at admission. Mechanical ventilation, extracorporeal membrane oxygenation (ECMO) requirements, and the use of vasopressor drugs were noted during ICU stay. To determine illness severity, SAPSII and SOFA scoring systems were applied to all patients within 24 h of ICU admission.Demographic characteristics and severity indices were recorded at ICU admission. MBL was assayed from blood drawn at influenza diagnosis within 24-48 h following the ICU admission. Outcomes were compared according to MBL levels.

Eligibility criteria: Inclusion Criteria:

* Patients who developed moderate-to-severe ARDS defined by the presence of bilateral alveolar images, a PaO2 / FiO2 ratio \<200 mmHg and the absence of an obvious cardiac cause, with or without the need for mechanical respiratory support extracorporeal circulation or decarboxylation.
* Patient benefiting from nitric oxide.
* Patient requiring continuous curarization.

Exclusion Criteria:

* Chronic renal insufficiency dialysis.
* Severe hepatic insufficiency.
* Patient under guardianship or curatorship or deprived of liberty.
* "light" ARDS

Primary outcomes:
measure: Levels of serum MBL are associated with mortality in critically ill patients with severe A(H1N1)pdm09 viral pneumonia.
timeFrame: 7days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Elie ZOGHEIB, MD
role: PRINCIPAL_INVESTIGATOR
References: