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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02003326
Acronym
AMIS
Enrollment
6
Registered
2013-12-06
Start date
2013-11-30
Completion date
2017-10-31
Last updated
2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

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.

Interventions

OTHERInflammatory markers

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHguntil the 13th daymeasure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13

Secondary

MeasureTime frameDescription
Mortality at D28at the 28th dayVerify if the patient is death at the 28th day
Ventilatory free days at D28at the 28th dayTo determine if the patient is free ventilatory at the 28th day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026