Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

January 12, 2013 updated by: S.K.SHARMA, All India Institute of Medical Sciences, New Delhi

Etiology and Outcomes of Acute Respiratory Distress Syndrome in Medical ICU in AIIMS

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

Study Overview

Status

Completed

Conditions

Detailed Description

The study will be a prospective observational study and 64 patients with ARDS will be recruited . Written informed consent will be taken prior to inclusion of study. Study will be conducted in Medical ICU (C2 ICU) of AIIMS. Based on medical history and physical examination, radiology, biochemical and microbiological investigations etiology of ARDS will be decided.Sample will be taken at te eime of admission for estimation of inflammatory markers hsCRP,IL-1.IL-6,TNF ,Procalcitonin.From the available variables APACHE II, Sequential organ failure assessment score (SOFA), Simplified acute physiological score (SAPS)II and 3 will be calculated to assess the severity of ARDS.All patients will be given mechanical ventilation using the protocol followed by the ARDS Network low-tidal volume ventilation strategy.The data will be registered on ICU admission and there after every 24 hr. Day 0 will be defined as the interval from the time of ICU admission to 8:00 am the next day .Every day data will be recorded at a fixed time at 9 am. It will include Tidal volume Vt (ml/kg),respiratory rate/min, Minute ventilation(l/min),FiO2,PaO2/FiO2,Inspiratory flow(I:E), Ppeak (cm of H2O),Static respiratory compliance(ml/cm of water).Plateau pressure (Pplat), Peak end expiratory pressure (PEEP).Patient will be monitored throughout the course of illness and the outcome of ARDS will be assessed.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110064
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient admitted in medical ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. HIV positive serology.
  2. Chronic obstructive airway disease
  3. Not giving consent for study
  4. Known lung pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patient fulfilling the criteria of ARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: with in 28 days after ICU admission
Outcome(mortality) 28 days after admission
with in 28 days after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: with in the discharge from the hopsital
Duration for which patient stays in hospital
with in the discharge from the hopsital
Duration of ICU stay
Time Frame: Duration for which patient stays in ICU after ICU admission
Duration for which patient stays in ICU
Duration for which patient stays in ICU after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Surendra K. Sharma, MD,Ph.D, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 12, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKS/Med/ARDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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