Study of Intensive Care Units in India (INDICAPS)
| Tracking Information | |||||
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| First Received Date ICMJE | June 28, 2011 | ||||
| Last Updated Date | June 28, 2011 | ||||
| Start Date ICMJE | July 2010 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
All cause mortality [ Time Frame: 30-days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Intensive Care Units in India | ||||
| Official Title ICMJE | Indian Intensive Care Case Mix and Practice Patterns Study | ||||
| Brief Summary | 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. |
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| 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
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 |
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| Condition ICMJE | Critical Illness | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | ICU patients
All patients present in the ICU on the selected days |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4236 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01384929 | ||||
| Other Study ID Numbers ICMJE | ISCCM01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | JV Divatia / Chairman, Clinical Research, Dr. Rajesh Chawla, President, Indian Society of Critical Care Medicine | ||||
| Study Sponsor ICMJE | Indian Society of Critical Care Medicine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Indian Society of Critical Care Medicine | ||||
| Verification Date | April 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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