Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

• Conditions: Multi-organ Failure; ARDS

• Registration Number: NCT01967602
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.

Detailed Description

The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.

Study Timeline

• Study Start: 2011-10
• Status Verified: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-22
• Last Update Submitted: 2013-10-22
• Study First Posted: 2013-10-23
• Last Update Posted: 2013-10-23
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. >18 years old
2. ARDS, needing ECMO support

Exclusion Criteria

1. pre-existing sepsis
2. pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or multi-organ failure	7 days	Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan