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: June 27, 2013
Last verified: June 2013
  Purpose

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: Double Blind (Subject, Caregiver, 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 hospital stay and stay in the intensive care unit [ Time Frame: From date of admission until date of discharge, assessed up to 1 month ] [ Designated as safety issue: No ]
    The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of intensive care unit stay, BNP levels in addition to standard clinical parameters will be evaluated.


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
Experimental: CHF peptide
Diuresis based on CHF-P
Drug: Furosemide
Based on clinical standard per clinician
Other Name: Brand name: Lasix
No Intervention: Non CHF peptide
Diuresis based on clinical judgement without data for CHF-P

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01584518

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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01584518     History of Changes
Other Study ID Numbers: 11-16126
Study First Received: April 11, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014