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B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading

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ClinicalTrials.gov Identifier: NCT01584518
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : March 28, 2016
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fluid Over-load
Intervention Drug: Furosemide
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CHF Peptide Non CHF Peptide
Hide Arm/Group Description

Diuresis based on CHF-P

Furosemide: Based on clinical standard per clinician

Diuresis based on clinical judgement without data for CHF-P
Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title CHF Peptide Non CHF Peptide Total
Hide Arm/Group Description

Diuresis based on CHF-P

Furosemide: Based on clinical standard per clinician

Diuresis based on clinical judgement without data for CHF-P Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
70  (10) 70  (9) 70  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
6
  24.0%
7
  28.0%
13
  26.0%
Male
19
  76.0%
18
  72.0%
37
  74.0%
1.Primary Outcome
Title Length of Stay
Hide Description The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay
Time Frame From date of admission until date of discharge, assessed up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CHF Peptide Non CHF Peptide
Hide Arm/Group Description:

Diuresis based on CHF-P

Furosemide: Based on clinical standard per clinician

Diuresis based on clinical judgement without data for CHF-P
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: days
4  (3) 6  (5)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CHF Peptide Non CHF Peptide
Hide Arm/Group Description

Diuresis based on CHF-P

Furosemide: Based on clinical standard per clinician

Diuresis based on clinical judgement without data for CHF-P
All-Cause Mortality
CHF Peptide Non CHF Peptide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CHF Peptide Non CHF Peptide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      4/25 (16.00%)    
Cardiac disorders     
Death   0/25 (0.00%)  0 2/25 (8.00%)  2
Renal and urinary disorders     
Acute renal failure   0/25 (0.00%)  0 2/25 (8.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CHF Peptide Non CHF Peptide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Anjan Talukdar
Organization: Creighton University
Phone: 402-280-3586
EMail: talukdar.anjan@gmail.com
Layout table for additonal information
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01584518     History of Changes
Other Study ID Numbers: 11-16126
First Submitted: April 11, 2012
First Posted: April 25, 2012
Results First Submitted: January 4, 2016
Results First Posted: March 28, 2016
Last Update Posted: May 27, 2016