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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967602
First Posted: October 23, 2013
Last Update Posted: October 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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.

Condition
ARDS Multi-organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Mortality or multi-organ failure [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Plasma, Cell, BALF, Urine

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted to National Taiwan University Hospital for acute respiratory distress syndrome needing ECMO placement.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967602


Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shuenn-Wen Kuo, MD    0972651448    shuenn@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shuenn-Wen Kuo, MD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01967602     History of Changes
Other Study ID Numbers: 201103056RB
First Submitted: October 18, 2013
First Posted: October 23, 2013
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
Acute respiratory distress syndrome (ARDS)
Extracorporeal membrane oxygenation (ECMO)
biomarker

Additional relevant MeSH terms:
Lung Injury
Multiple Organ Failure
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Shock
Pathologic Processes