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

• ClinicalTrials.gov Identifier: NCT01584518
• Recruitment Status: Completed
• First Posted: April 25, 2012
• Results First Posted: March 28, 2016
• Last Update Posted: May 27, 2016
• Sponsor: Creighton University
• Information provided by (Responsible Party): Creighton University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Creighton University
• ClinicalTrials.gov Identifier: NCT01584518
• Other Study ID Numbers: 11-16126
• First Posted: April 25, 2012
• Results First Posted: March 28, 2016
• Last Update Posted: May 27, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Furosemide; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Potassium Chloride Symporter Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action