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

NCT03641690 | Completed

• 1 other identifier: RNI2013-ZOGHEIB
• Study Type: observational
• Target: 97
• Locations: 0 countries
• Sites: N/A

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.

Conditions

H1N1 Influenza

Keywords

pandemic influenza; mortality; ICU

Outcome Measures

Primary Outcomes (1)

• Levels of serum MBL are associated with mortality in critically ill patients with severe A(H1N1)pdm09 viral pneumonia.

  The aim of the present study was to determine whether levels of serum MBL are associated with mortality in critically ill patients with severe A(H1N1)pdm09 viral pneumonia. When a patient met criteria for ARDS, the closest residual blood sample taken on the same day was obtained from the central hospital laboratory in the 24-48 h following the intubation or in the acute phase of the viral infection. MBL serum concentrations were assayed by an Oligomer ELISA kit (BioPorto) according to the manufacturer's instructions. Results are expressed as median \[interquartile range (IQR)\] or number (percent). Survivors were compared with nonsurvivors using the Mann-Whitney U test for continuous variables and Chi2 test for categorical variables with Yates' correction or Fisher's exact test if necessary. A correlation was searched between MBL and inflammatory parameters using spearman test.

  7days

Study Arms (2)

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

Other: Empirical antimicrobial therapy

70 control

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

Interventions

Empirical antimicrobial therapy 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.

27 case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Elie ZOGHEIB, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share