B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading
B-type Natriuretic Peptide (BNP) as a Surrogate Marker Guiding Post-operative Fluid Off-loading
1 other identifier
interventional
50
1 country
1
Brief Summary
The long-range goal of this proposal is to decrease morbidity and mortality related to pulmonary edema and congestive heart failure (CHF) in post-operative patients. The short-range goal is to determine a mechanistic endpoint when therapy for impending heart failure can be initiated and terminated based on B-type natriuretic peptide (BNP) levels. The investigators propose to utilize changing levels of BNP as a surrogate marker for CHF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
March 28, 2016
CompletedMay 27, 2016
April 1, 2016
11 months
April 11, 2012
January 4, 2016
April 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Stay
The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay
From date of admission until date of discharge, assessed up to 1 month
Study Arms (2)
CHF peptide
ACTIVE COMPARATORDiuresis based on CHF-P
Non CHF peptide
ACTIVE COMPARATORDiuresis based on clinical judgement without data for CHF-P
Interventions
Based on clinical standard per clinician
Eligibility Criteria
You may qualify if:
- General Surgery patients with history of coronary artery disease, congestive heart failure, pulmonary hypertension
- Cardiac surgery patients undergoing CABG (coronary artery bypass grafting) and valve replacements
You may not qualify if:
- Recent myocardial infarction (within 3 months).
- ASA class 4 and more.
- Emergency surgeries.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Anjan Talukdar
- Organization
- Creighton University
Study Officials
- PRINCIPAL INVESTIGATOR
Anjan J Talukdar, MD
Creighton University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 25, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
May 27, 2016
Results First Posted
March 28, 2016
Record last verified: 2016-04