Etiology and Outcomes of Tropical Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01450527
First received: October 10, 2011
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Etiology and Outcomes of Acute Respiratory Distress Syndrome in Medical ICU in AIIMS

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: with in 28 days after ICU admission ] [ Designated as safety issue: No ]
    Outcome(mortality) 28 days after admission


Secondary Outcome Measures:
  • Duration of hospital stay [ Time Frame: with in the discharge from the hopsital ] [ Designated as safety issue: No ]
    Duration for which patient stays in hospital

  • Duration of ICU stay [ Time Frame: Duration for which patient stays in ICU after ICU admission ] [ Designated as safety issue: No ]
    Duration for which patient stays in ICU


Enrollment: 64
Study Start Date: July 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient fulfilling the criteria of ARDS

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient admitted in medical ICU

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450527

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

No publications provided

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
Study First Received: October 10, 2011
Last Updated: January 12, 2013
Health Authority: India: Ministry of Health

Keywords provided by 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
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on August 21, 2014