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Study of Intensive Care Units in India (INDICAPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384929
First Posted: June 29, 2011
Last Update Posted: June 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Indian Society of Critical Care Medicine
  Purpose
There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most of the available data comes from single centre studies. There is a dire need to have data from Indian ICUs to reflect the vast spectrum of critical care illness, services and practices. INDICAPS planned to collect data of all patients in the ICU on one particular day, and four such days spread throughout a one-year period were selected: the second Wednesday of July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the country as possible were asked to participate. The investigators aimed to gather information about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic modalities used, types of infections,mortality rates, etc.

Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Indian Intensive Care Case Mix and Practice Patterns Study

Resource links provided by NLM:


Further study details as provided by Indian Society of Critical Care Medicine:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30-days ]

Secondary Outcome Measures:
  • ICU Length of stay [ Time Frame: 30 days ]
    Stay in ICU till 30 days

  • Hospital length of stay [ Time Frame: 30 days ]
    Stay in hospital till 30 days

  • Hospital survival [ Time Frame: 30 days ]
    Survival at hospital discharge or at 30 days


Enrollment: 4236
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients
All patients present in the ICU on the selected days

Detailed Description:

The following information will be analysed:

Case-mix, severity of illness, prevalence of infection, hemodynamic monitoring and therapy, mechanical ventilation practices, nutrition and outcome

  • Seasonal and regional variations in the above
  • Epidemiology and variations in antibiotic use
  • Patterns of microorganisms and outcome
  • Prevalence and outcome of specific tropical febrile illnesses, including malaria, dengue fever, leptospirosis, scrub typhus
  • Prevalence and outcome of toxins and poisonings
  • Relation of ICU and hospital organizational issues to prevalence of infection and outcome
  • Organisation of intensive care services
  • End of life - Ethical decisions
  Eligibility

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:   Non-Probability Sample
Study Population
All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011
Criteria

Inclusion Criteria:

  • All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011
  Contacts and Locations
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): NCT01384929


Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400058
Sponsors and Collaborators
Indian Society of Critical Care Medicine
Investigators
Study Chair: Jigeeshu Divatia, MD Indian Society of Critical Care Medicine
  More Information

Responsible Party: JV Divatia / Chairman, Clinical Research, Dr. Rajesh Chawla, President, Indian Society of Critical Care Medicine
ClinicalTrials.gov Identifier: NCT01384929     History of Changes
Other Study ID Numbers: ISCCM01
First Submitted: June 28, 2011
First Posted: June 29, 2011
Last Update Posted: June 30, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes