NCT01450527

Brief Summary

This is a prospective observational study done to know the etiology and outcomes of Acute Respiratory Distress Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

October 10, 2011

Last Update Submit

January 12, 2013

Conditions

Acute Respiratory Distress Syndrome

Keywords

Etiology and outcomes of ARDS

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Outcome(mortality) 28 days after admission

    with in 28 days after ICU admission

Secondary Outcomes (2)

  • Duration of hospital stay

    with in the discharge from the hopsital

  • Duration of ICU stay

    Duration for which patient stays in ICU after ICU admission

Study Arms (1)

Patient fulfilling the criteria of ARDS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient admitted in medical ICU

You may qualify if:

  • Subjects fulfilling the criteria of ARDS according to American-European consensus definition
  • Admitted in medical ICU(CII/CU)
  • No known previous lung pathology e.g. bronchiectasis, Interstitial lung disease

You may not qualify if:

  • HIV positive serology.
  • Chronic obstructive airway disease
  • Not giving consent for study
  • Known lung pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110064, India

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Surendra K. Sharma, MD,Ph.D

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HOD Medicine

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 12, 2011

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

IN(1)