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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 25, 2012
Last Update Posted: May 27, 2016
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.
Information provided by (Responsible Party):
Creighton University
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 Intervention
Fluid Over-load Drug: Furosemide

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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

Enrollment: 50
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01584518

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Anjan J Talukdar, MD Creighton University Medical Center
  More 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
Last Verified: April 2016

Additional relevant MeSH terms:
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action