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

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

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 month

The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay

Outcome measures

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

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

Dr Anjan Talukdar

Creighton University

Phone: 402-280-3586

Results disclosure agreements

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