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

Acute Respiratory Distress Syndrome Clinical Trial

— AMIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02003326
• Other study ID #: 13AOI07
• Status: Terminated
• Phase: N/A
• First received: November 7, 2013
• Last updated: October 3, 2017
• Start date: November 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Inflammation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Inflammatory markers

Locations

Country	Name	City	State
France	Réanimation Médicale CHU de Nice - Hôpital de l'Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg	measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13	until the 13th day
Secondary	Mortality at D28	Verify if the patient is death at the 28th day	at the 28th day
Secondary	Ventilatory free days at D28	To determine if the patient is free ventilatory at the 28th day	at the 28th day