Trial Outcomes & Findings for Second Survey of Intensive Care in India (NCT NCT03631927)
NCT ID: NCT03631927
Last Updated: 2021-11-11
Results Overview
Number of patients who died in the ICU, as well as those terminally discharged from the ICU
Recruitment status
COMPLETED
Target enrollment
5094 participants
Primary outcome timeframe
30 days from the study day
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
Patients
All patients present in the ICU on the study days were included in the study. Data were recorded for all patients present in the ICU during the 24 hours starting from 08.00 a.m. on the study day to 08.00 a.m. the next day. Neonatal and pediatric ICUs were not included. There were no other exclusion criteria.
|
|---|---|
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Overall Study
STARTED
|
5094
|
|
Overall Study
COMPLETED
|
4669
|
|
Overall Study
NOT COMPLETED
|
425
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Second Survey of Intensive Care in India
Baseline characteristics by cohort
| Measure |
Single Cohort
n=4669 Participants
All patients \> 15 years of age present in the intensive care unit on the study days
|
|---|---|
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Age, Continuous
|
56.9 years
STANDARD_DEVIATION 17.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1696 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2973 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Asian (Indian) ethnicity 4669 · Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Asian (Indian) ethnicity 4669 · Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Asian (Indian) ethnicity 4669 · Unknown or Not Reported
|
4669 Participants
n=93 Participants
|
|
Region of Enrollment
India
|
4669 participants
n=93 Participants
|
|
Age > 15 years
|
4669 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 days from the study dayNumber of patients who died in the ICU, as well as those terminally discharged from the ICU
Outcome measures
| Measure |
Single Cohort
n=4669 Participants
All patients \> 15 years of age present in the intensive care unit on the study days
|
|---|---|
|
ICU Mortality
|
1092 Participants
|
SECONDARY outcome
Timeframe: 30 days from the study dayall cause hospital mortality, including those terminally discharged from the ICU
Outcome measures
| Measure |
Single Cohort
n=4669 Participants
All patients \> 15 years of age present in the intensive care unit on the study days
|
|---|---|
|
Hospital Mortality
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1164 Participants
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SECONDARY outcome
Timeframe: upto 30 days from the study daylength of stay in the intensive care unit
Outcome measures
| Measure |
Single Cohort
n=4669 Participants
All patients \> 15 years of age present in the intensive care unit on the study days
|
|---|---|
|
ICU Length of Stay
|
6 days
Interval 3.0 to 13.0
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SECONDARY outcome
Timeframe: upto 30 days from the study daylength of stay in the hospital
Outcome measures
| Measure |
Single Cohort
n=4669 Participants
All patients \> 15 years of age present in the intensive care unit on the study days
|
|---|---|
|
Hospital Length of Stay
|
12 Days
Interval 7.0 to 20.0
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Adverse Events
Single Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1164 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place