Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT01450527
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-12
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	with in 28 days after ICU admission	Outcome(mortality) 28 days after admission

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	with in the discharge from the hopsital	Duration for which patient stays in hospital
Duration of ICU stay	Duration for which patient stays in ICU after ICU admission	Duration for which patient stays in ICU

Trial Locations

Locations (1)

All India Institute Of Medical Sciences; 🇮🇳 New Delhi, Delhi, India