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Not yet recruiting NCT07675265

Observational, Non-interventional Biomarker and Endotyping Study

— Observational ARDS (Acute Respiratory Distress Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ARDS (Acute Respiratory Distress Syndrome). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Observational Biomarker Study for the Evaluation of Response and Validation of Endotypes in Acute Respiratory Distress Syndrome

Overview

The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop unsupervised, therapy-specific treatment-prediction algorithms over a 24 month period.

Primary outcome measures

  • Number of Participants with an ARDS Diagnosis [Time frame: from enrollment to 28-day in-hospital mortality]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • ARDS Diagnosis (New Global Definition of ARDS)
  • Timing: Acute onset within 7 days
  • Radiology: Bilateral pulmonary opacities
  • Hypoxia:

Non-intubated ARDS: PaO2:FIO2<300mmHg or SpO2:FIO2<315 (if SpO2<97%) on HFNO with flow of >30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure; or Intubated ARDS: PaO2:FIO2<300 mm Hg or SpO2:FIO2<315 (if SpO2<97%)

  • ICU admission
  • Enrolled within 72 hours of meeting inclusion criteria

Exclusion criteria

  • Primary cardiogenic pulmonary edema

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07675265 · CLN-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗