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

NCT02003326 | Terminated

• 1 other identifier: 13AOI07
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality at D28

  at the 28th day

• Ventilatory free days at D28

  at the 28th day

Study Arms (1)

Inflammatory markers

OTHER

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

Interventions

Inflammatory markers OTHER

Inflammatory markers

Eligibility Criteria

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

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Réanimation Médicale CHU de Nice - Hôpital de l'Archet

Nice, 06003, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jean DELLAMONICA, MD

  CHU de Nice Hôpital de l'Archet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

FR (1)