Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

ARDS Clinical Trial

— ARDS  

Official title:

Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01967602
• Other study ID #: 201103056RB
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2013
• Last updated: October 22, 2013
• Start date: October 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ARDS
• Lung Injury
• Multi-organ Failure
• Multiple Organ Failure

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality or multi-organ failure	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.	7 days	No