Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain) (AMIS)
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|ClinicalTrials.gov Identifier: NCT02003326|
Recruitment Status : Terminated (low number of patients enrolled)
First Posted : December 6, 2013
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Other: Inflammatory markers||Not Applicable|
Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.
The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.
Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
All patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers. All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat <30cmH2O). End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation.
Other: Inflammatory markers
- measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg [ Time Frame: until the 13th day ]measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
- Mortality at D28 [ Time Frame: at the 28th day ]Verify if the patient is death at the 28th day
- Ventilatory free days at D28 [ Time Frame: at the 28th day ]To determine if the patient is free ventilatory at the 28th day
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): NCT02003326
|Réanimation Médicale CHU de Nice - Hôpital de l'Archet|
|Nice, France, 06003|
|Principal Investigator:||Jean DELLAMONICA, MD||CHU de Nice Hôpital de l'Archet|