Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support (ARDS)

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.

Study Overview

• Status: Unknown
• Conditions: ARDS; Multi-organ Failure

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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Shuenn-Wen Kuo, MD; Phone Number: 0972651448; Email: shuenn@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are admitted to National Taiwan University Hospital for acute respiratory distress syndrome needing ECMO placement.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Shuenn-Wen Kuo, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: biomarker; Acute respiratory distress syndrome (ARDS); Extracorporeal membrane oxygenation (ECMO)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Shock; Thoracic Injuries; Lung Injury; Multiple Organ Failure
• Other Study ID Numbers: 201103056RB