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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01584518
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : March 28, 2016
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
Creighton University

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.

Condition or disease Intervention/treatment Phase
Fluid Over-load Drug: Furosemide Not Applicable

Detailed Description:

Creighton University Medical Center is 334-bed Level I Trauma Center that hosts a wide variety of surgical and trauma patients. Many of these patients, including and especially those with pre-existing cardiac morbidities, develop symptoms of congestive heart failure (CHF) following trauma or surgical intervention because of a combination of physiological factors including third spacing followed by self-diuresis, and decreased contractility post injury. Normally, following the onset of CHF, surgeons begin treatment based on their clinical judgment of hemodynamic parameters and radiographic findings. CHF is known to increase morbidity, mortality, hospital length of stay and overall expenditure to the health care system and preventative measures and directed treatment modalities have potential to improve patient care and healthcare economics.

BNP, also known as beta-natriuretic protein or CHF peptide, is a cardiac neuro-hormone synthesized by the cardiac myocytes. It is released as a preproBNP peptide of 134 amino acids and is cleaved into proBNP (108 amino acids) and a signal peptide of 26 amino acids. ProBNP is subsequently cleaved into BNP (32 amino acids) and the inactive N-terminal proBNP peptide (NBNP; 76 amino acids). The effects of BNP are vasodilation, natriuresis and diuresis1.

Left ventricular end-diastolic wall stress (EDWS) measurement and ejection fraction are well established surrogates to predict the onset of CHF but require the invasive procedure of cardiac catheterization.

The mainstay of the treatment of CHF is diuretic drugs to try to remove excess fluid from the patient. In this project we plan to identify patients at risk for CHF and divide them into two groups. In one group BNP will be used to guide diuretic dosage and in the other conventional clinical parameters will be used.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: B-type Natriuretic Peptide (BNP) as a Surrogate Marker Guiding Post-operative Fluid Off-loading
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: CHF peptide
Diuresis based on CHF-P
Drug: Furosemide
Based on clinical standard per clinician
Other Name: Brand name: Lasix

Active Comparator: Non CHF peptide
Diuresis based on clinical judgement without data for CHF-P
Drug: Furosemide
Based on clinical standard per clinician
Other Name: Brand name: Lasix

Primary Outcome Measures :
  1. Length of Stay [ Time Frame: 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

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Recent myocardial infarction (within 3 months).
  2. ASA class 4 and more.
  3. Emergency surgeries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01584518

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United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
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Principal Investigator: Anjan J Talukdar, MD Creighton University Medical Center

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Responsible Party: Creighton University Identifier: NCT01584518     History of Changes
Other Study ID Numbers: 11-16126
First Posted: April 25, 2012    Key Record Dates
Results First Posted: March 28, 2016
Last Update Posted: May 27, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action