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

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.
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

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
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 day

Number of patients who died in the ICU, as well as those terminally discharged from the ICU

Outcome measures

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 day

all cause hospital mortality, including those terminally discharged from the ICU

Outcome measures

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
1164 Participants

SECONDARY outcome

Timeframe: upto 30 days from the study day

length of stay in the intensive care unit

Outcome measures

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

SECONDARY outcome

Timeframe: upto 30 days from the study day

length of stay in the hospital

Outcome measures

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

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

Dr. Jigeeshu Divatia

Tata Memorial Hospital

Phone: +919869077435

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place