NCT01967602

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

3.5 years

First QC Date

October 18, 2013

Last Update Submit

October 22, 2013

Conditions

ARDSMulti-organ Failure

Keywords

Acute respiratory distress syndrome (ARDS)Extracorporeal membrane oxygenation (ECMO)biomarker

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>18 years old
  • ARDS, needing ECMO support

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Cell, BALF, Urine

MeSH Terms

Conditions

Multiple Organ FailureRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Shuenn-Wen Kuo, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

October 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

TW(1)