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CompletedNCT01450527Updated Jan 15, 2013

Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

An observational study in Acute Respiratory Distress Syndrome, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2013-01-15.

Sponsored by All India Institute of Medical Sciences, New Delhi · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
64
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Etiology and outcomes of ARDS
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 64 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient admitted in medical ICU

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

Exclusion Criteria:

  1. HIV positive serology.
  2. Chronic obstructive airway disease
  3. Not giving consent for study
  4. Known lung pathology
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient fulfilling the criteria of ARDS
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What researchers measure

Primary outcomes

  1. 28-day mortality

    Outcome(mortality) 28 days after admission

    Time frame: with in 28 days after ICU admission

Secondary outcomes

  1. Duration of hospital stay

    Duration for which patient stays in hospital

    Time frame: with in the discharge from the hopsital

  2. Duration of ICU stay

    Duration for which patient stays in ICU

    Time frame: Duration for which patient stays in ICU after ICU admission

07

Study locations

1 site
  • All India Institute Of Medical Sciences
    New Delhi, Delhi 110064, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01450527
Lead sponsor
All India Institute of Medical Sciences, New Delhi
Responsible party
S.K.SHARMA (HOD Medicine, All India Institute of Medical Sciences, New Delhi) — Principal investigator
First posted
Oct 12, 2011
Start date
Jul 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jan 15, 2013

Study contacts

Surendra K. Sharma, MD,Ph.D
principal investigator · All India Institute of Medical Sciences, New Delhi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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