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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01584518
First received: April 11, 2012
Last updated: April 28, 2016
Last verified: April 2016
Results First Received: January 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fluid Over-load
Intervention: Drug: Furosemide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    CHF Peptide   Non CHF Peptide
STARTED   25   25 
COMPLETED   25   25 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   CHF Peptide   Non CHF Peptide   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 70  (10)   70  (9)   70  (9.5) 
Gender 
[Units: Participants]
     
Female   6   7   13 
Male   19   18   37 


  Outcome Measures

1.  Primary:   Length of Stay   [ Time Frame: From date of admission until date of discharge, assessed up to 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Anjan Talukdar
Organization: Creighton University
phone: 402-280-3586
e-mail: talukdar.anjan@gmail.com



Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01584518     History of Changes
Other Study ID Numbers: 11-16126
Study First Received: April 11, 2012
Results First Received: January 4, 2016
Last Updated: April 28, 2016
Health Authority: United States: Institutional Review Board