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Clinical Trials/NCT01450527
NCT01450527
Completed
Not Applicable

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

All India Institute of Medical Sciences, New Delhi1 site in 1 country64 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
All India Institute of Medical Sciences, New Delhi
Enrollment
64
Locations
1
Primary Endpoint
28-day mortality
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
June 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
All India Institute of Medical Sciences, New Delhi
Responsible Party
Principal Investigator
Principal Investigator

S.K.SHARMA

HOD Medicine

All India Institute of Medical Sciences, New Delhi

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

28-day mortality

Time Frame: with in 28 days after ICU admission

Outcome(mortality) 28 days after admission

Secondary Outcomes

  • 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 Sites (1)

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