Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

Not Applicable

Terminated

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Inflammatory markers

• Registration Number: NCT02003326
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

Detailed Description

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Moderate to severe ARDS (Berlin Definition)
• Acute beginning <1 week
• PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
• Bilateral opacities on chest X-ray
• Respiratory failure not fully explain by cardiac failure or fluid overload
• Informed consent signed by the next of kin and secondarily by the patient when awake
• Patient with social insurance

No Inclusion criteria

• Age < 18
• Pregnancy a pregnancy test will be done to women of childbearing age
• Chronic obstructive pulmonary disease
• Severe hypoxemia PaO2/FiO2 <50% with high PEEP
• Immunosuppressive treatment
• Immunodeficiency onco-hematology, HIV

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inflammatory markers	Inflammatory markers	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.

Primary Outcome Measures

Name	Time	Method
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg	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

Secondary Outcome Measures

Name	Time	Method
Mortality at D28	at the 28th day	Verify if the patient is death at the 28th day
Ventilatory free days at D28	at the 28th day	To determine if the patient is free ventilatory at the 28th day

Trial Locations

Locations (1)

Réanimation Médicale CHU de Nice - Hôpital de l'Archet; 🇫🇷 Nice, France