Clinical Trials Directory

Trials / Completed

CompletedNCT03641690

Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome

Evolution of Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome (ARDS) Without or With Extracorporeal Mechanical Assistance

Status
Completed
Phase
Study type
Observational
Enrollment
97 (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHEREmpirical antimicrobial therapyAll patients with pulmonary symptoms received empirical antimicrobial therapy with ceftriaxone and rovamycin or levofloxacin on admission and this was subsequently adapted to any documented bacterial infection if positive.

Timeline

Start date
2013-09-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2018-08-22
Last updated
2023-05-17

Source: ClinicalTrials.gov record NCT03641690. Inclusion in this directory is not an endorsement.