Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450527
• Other study ID #: SKS/Med/ARDS
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: January 12, 2013
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
India	All India Institute Of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Outcome(mortality) 28 days after admission	with in 28 days after ICU admission	No
Secondary	Duration of hospital stay	Duration for which patient stays in hospital	with in the discharge from the hopsital	No
Secondary	Duration of ICU stay	Duration for which patient stays in ICU	Duration for which patient stays in ICU after ICU admission	No