B-type Natriuretic Peptide as a Surrogate Marker Guiding Post-operative Fluid Off-loading
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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 |
- 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
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:
- Recent myocardial infarction (within 3 months).
- ASA class 4 and more.
- Emergency surgeries.
Contacts and Locations| Contact: Anjan J Talukdar, MD | 4025476010 | anjantalukdar@creihton.edu |
| United States, Nebraska | |
| Creighton University Medical Center | Not yet recruiting |
| Omaha, Nebraska, United States, 68131 | |
| Contact: Anjan J Talukdar, MD | |
| Principal Investigator: Anjan J Talukdar, MD | |
| 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: | July 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Water-Electrolyte Imbalance Water Intoxication Metabolic Diseases Poisoning Substance-Related Disorders Furosemide Natriuretic Peptide, Brain Sodium Potassium Chloride Symporter Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013