Clinical Trial: Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome: 28-day mortality [ Time Frame: with in 28 days after ICU admission ]

Outcome(mortality) 28 days after admission


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of hospital stay [ Time Frame: with in the discharge from the hopsital ]
    Duration for which patient stays in hospital
  • Duration of ICU stay [ Time Frame: Duration for which patient stays in ICU after ICU admission ]
    Duration for which patient stays in ICU


Original Secondary Outcome:

  • Duration of hospital stay
    Duration for which patient stays in hospital
  • Duration of ICU stay
    Duration for which patient stays in ICU
  • PFT after 3 months of discharge [ Time Frame: 3 Months ]
    Assessment of lung function


Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: October 10, 2011
Date Started: July 2010
Date Completion:
Last Updated: January 12, 2013
Last Verified: January 2013