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

NCT ID: NCT03641690

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-01
• Study Completion Date: 2017-12-01

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.

Conditions

H1N1 Influenza

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

27 case

Twenty-seven patients were admitted to the ICU with severe pneumonia and with a high probability of viral infection or a previously confirmed diagnosis received Empirical antimicrobial therapy

Empirical antimicrobial therapy

Intervention Type: OTHER

All 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.

70 control

70 healthy subjects (HS) among blood donors attending the Regional Center for Blood Transfusion (Lille, France).

No interventions assigned to this group

Interventions

Empirical antimicrobial therapy

All 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elie ZOGHEIB, MD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Other Identifiers

RNI2013-ZOGHEIB

Identifier Type: -

Identifier Source: org_study_id