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

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ClinicalTrials.gov Identifier: NCT03641690
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment
H1N1 Influenza Other: Empirical antimicrobial therapy

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.


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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evolution of Serum and Bronchoalveolar Inflammatory Parameters in Patients With Severe Adult Respiratory Distress Syndrome (ARDS) Without or With Extracorporeal Mechanical Assistance
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017


Group/Cohort Intervention/treatment
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
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).



Primary Outcome Measures :
  1. Levels of serum MBL are associated with mortality in critically ill patients with severe A(H1N1)pdm09 viral pneumonia. [ Time Frame: 7days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641690


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Elie ZOGHEIB, MD CHU AMIENS

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03641690     History of Changes
Other Study ID Numbers: RNI2013-ZOGHEIB
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
pandemic influenza
mortality
ICU
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Anti-Bacterial Agents
Anti-Infective Agents