Study of Intensive Care Units in India (INDICAPS)

This study has been completed.
Sponsor:
Information provided by:
Indian Society of Critical Care Medicine
ClinicalTrials.gov Identifier:
NCT01384929
First received: June 28, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Stay in ICU till 30 days

  • Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Stay in hospital till 30 days

  • Hospital survival [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 28, 2011
Last Updated: June 28, 2011
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014