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Completed

NCT Number: NCT01450527

Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

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

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110064, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 28-day mortality

    Time frame: with in 28 days after ICU admission

    Outcome(mortality) 28 days after admission

Secondary outcomes

  1. Duration of hospital stay

    Time frame: with in the discharge from the hopsital

    Duration for which patient stays in hospital

  2. Duration of ICU stay

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

    Duration for which patient stays in ICU

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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