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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Over-load
• Intervention / Treatment: Drug: Furosemide

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CHF peptide; Diuresis based on CHF-P	Drug: Furosemide; Based on clinical standard per clinician; Other Names: 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 Names: Brand name: Lasix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Creighton University
• Investigators: Principal Investigator: Anjan J Talukdar, MD, Creighton University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 11-16126