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

NCT ID: NCT02003326

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Inflammatory markers

Intervention Type OTHER

Interventions

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Inflammatory markers

Intervention Type OTHER

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean DELLAMONICA, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice Hôpital de l'Archet

Locations

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Réanimation Médicale CHU de Nice - Hôpital de l'Archet

Nice, , France

Site Status

Countries

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France

Other Identifiers

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13AOI07

Identifier Type: -

Identifier Source: org_study_id