Trial Outcomes & Findings for Early Warning System (NCT NCT01741480)
NCT ID: NCT01741480
Last Updated: 2022-05-11
Results Overview
Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
571 participants
Primary outcome timeframe
Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
Routine Care
General hospital ward patients will receive routine care.
routine care =286
|
Intervention Arm
Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.
Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
286
|
|
Overall Study
COMPLETED
|
285
|
286
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Warning System
Baseline characteristics by cohort
| Measure |
Routine Care
n=285 Participants
General hospital ward patients will receive routine care.
routine care
|
Intervention Arm
n=286 Participants
Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.
Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University.
|
Total
n=571 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 16 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
285 participants
n=5 Participants
|
286 participants
n=7 Participants
|
571 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.
Outcome measures
| Measure |
Routine Care
n=285 Participants
General hospital ward patients will receive routine care.
routine care =286
|
Intervention Arm
n=286 Participants
Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration.
Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285
|
|---|---|---|
|
ICU Transfer
|
52 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Patients will be asessed for the secondary outcome measure during an average of 28 days..Death during hospitalization will be used to determine the presence of this outcome.
Outcome measures
Outcome data not reported
Adverse Events
Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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