Trial Outcomes & Findings for Effect of Body Weight Change to Surgical ICU Outcomes (NCT NCT01351506)
NCT ID: NCT01351506
Last Updated: 2014-11-07
Results Overview
28 days mortality if patient still have be admitted in hospital.
Recruitment status
COMPLETED
Target enrollment
465 participants
Primary outcome timeframe
within 28 days after ICU admission to dead
Results posted on
2014-11-07
Participant Flow
Participant milestones
| Measure |
Cohort Patient
A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
|
|---|---|
|
Overall Study
STARTED
|
602
|
|
Overall Study
COMPLETED
|
465
|
|
Overall Study
NOT COMPLETED
|
137
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Body Weight Change to Surgical ICU Outcomes
Baseline characteristics by cohort
| Measure |
ICU Survivors
n=395 Participants
Patients who survivors from ICU discharge status
|
ICU Non Survivors
n=70 Participants
Patients who non survivors from ICU discharge status
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
53 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
286 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 28 days after ICU admission to deadPopulation: Total 465 patients
28 days mortality if patient still have be admitted in hospital.
Outcome measures
| Measure |
</= 5%
n=306 Participants
Maximum weight change upto 7 days less than or equal to 5% of admission body weight
|
> 5%
n=159 Participants
Maximum weight change upto 7 days more than 5% of admission weight
|
|---|---|---|
|
In Hospital Mortality
|
52 participants
|
44 participants
|
SECONDARY outcome
Timeframe: ICU complications up to 28 days after ICU admissionPopulation: All
Patient who need re-intubation within 72 hours
Outcome measures
| Measure |
</= 5%
n=306 Participants
Maximum weight change upto 7 days less than or equal to 5% of admission body weight
|
> 5%
n=159 Participants
Maximum weight change upto 7 days more than 5% of admission weight
|
|---|---|---|
|
Re Intubation Within 72 Hours
|
12 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Acute kidney injuryNew acute kidney injury in ICU
Outcome measures
| Measure |
</= 5%
n=306 Participants
Maximum weight change upto 7 days less than or equal to 5% of admission body weight
|
> 5%
n=159 Participants
Maximum weight change upto 7 days more than 5% of admission weight
|
|---|---|---|
|
Acute Kidney Injury
|
68 participants
|
51 participants
|
Adverse Events
</= 5%
Serious events: 11 serious events
Other events: 38 other events
Deaths: 0 deaths
> 5%
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
</= 5%
n=306 participants at risk
Maximum weight change upto 7 days less than or equal to 5% of admission body weight
|
> 5%
n=159 participants at risk
Maximum weight change upto 7 days more than 5% of admission weight
|
|---|---|---|
|
Renal and urinary disorders
Renal replacement therapy
|
3.6%
11/306 • Number of events 11 • up to 28 days after ICU admission
Events occurring within 28 days after ICU admission
|
11.9%
19/159 • Number of events 19 • up to 28 days after ICU admission
Events occurring within 28 days after ICU admission
|
Other adverse events
| Measure |
</= 5%
n=306 participants at risk
Maximum weight change upto 7 days less than or equal to 5% of admission body weight
|
> 5%
n=159 participants at risk
Maximum weight change upto 7 days more than 5% of admission weight
|
|---|---|---|
|
Nervous system disorders
Delirium
|
12.4%
38/306 • Number of events 38 • up to 28 days after ICU admission
Events occurring within 28 days after ICU admission
|
23.3%
37/159 • Number of events 37 • up to 28 days after ICU admission
Events occurring within 28 days after ICU admission
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place