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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Inflammatory markers
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Réanimation Médicale CHU de Nice - Hôpital de l'Archet

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inflammatory markers

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2013
Last Updated
October 3, 2017
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02003326
Brief Title
Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
Acronym
AMIS
Official Title
Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
low number of patients enrolled
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inflammatory markers
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inflammatory markers
Primary Outcome Measure Information:
Title
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg
Description
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13
Time Frame
until the 13th day
Secondary Outcome Measure Information:
Title
Mortality at D28
Description
Verify if the patient is death at the 28th day
Time Frame
at the 28th day
Title
Ventilatory free days at D28
Description
To determine if the patient is free ventilatory at the 28th day
Time Frame
at the 28th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean DELLAMONICA, MD
Organizational Affiliation
CHU de Nice Hôpital de l'Archet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation Médicale CHU de Nice - Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06003
Country
France

12. IPD Sharing Statement

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

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