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Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT01450527
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
S.K.SHARMA, 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.

Condition or disease
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 Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Etiology and Outcomes of Acute Respiratory Distress Syndrome in Medical ICU in AIIMS
Study Start Date : July 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Patient fulfilling the criteria of ARDS

Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: with in 28 days after ICU admission ]
    Outcome(mortality) 28 days after admission

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450527

All India Institute Of Medical Sciences
New Delhi, Delhi, India, 110064
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Principal Investigator: Surendra K. Sharma, MD,Ph.D All India Institute of Medical Sciences, New Delhi

Responsible Party: S.K.SHARMA, HOD Medicine, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01450527     History of Changes
Other Study ID Numbers: SKS/Med/ARDS
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:
Etiology and outcomes of ARDS

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury