Trial Outcomes & Findings for B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading (NCT NCT01584518)
NCT ID: NCT01584518
Last Updated: 2016-05-27
Results Overview
The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
From date of admission until date of discharge, assessed up to 1 month
Results posted on
2016-05-27
Participant Flow
Participant milestones
| Measure |
CHF Peptide
Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician
|
Non CHF Peptide
Diuresis based on clinical judgement without data for CHF-P
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading
Baseline characteristics by cohort
| Measure |
CHF Peptide
n=25 Participants
Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician
|
Non CHF Peptide
n=25 Participants
Diuresis based on clinical judgement without data for CHF-P
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 10 • n=5 Participants
|
70 years
STANDARD_DEVIATION 9 • n=7 Participants
|
70 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of admission until date of discharge, assessed up to 1 monthThe subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay
Outcome measures
| Measure |
CHF Peptide
n=25 Participants
Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician
|
Non CHF Peptide
n=25 Participants
Diuresis based on clinical judgement without data for CHF-P
|
|---|---|---|
|
Length of Stay
|
4 days
Standard Deviation 3
|
6 days
Standard Deviation 5
|
Adverse Events
CHF Peptide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non CHF Peptide
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CHF Peptide
n=25 participants at risk
Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician
|
Non CHF Peptide
n=25 participants at risk
Diuresis based on clinical judgement without data for CHF-P
|
|---|---|---|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/25 • 8 months
|
8.0%
2/25 • Number of events 2 • 8 months
|
|
Cardiac disorders
Death
|
0.00%
0/25 • 8 months
|
8.0%
2/25 • Number of events 2 • 8 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place