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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

NCT00618852

Lung Disease

UNKNOWN PHASE3

The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia

NCT01748331

Heart Failure Hyponatremia

UNKNOWN NA

Hypertonic Saline Therapy in Ambulatory Heart Failure Unit.

NCT04533997

Heart Failure

COMPLETED PHASE3

Evaluation of Plasma Volume Using Ultrasound in Disorders of Fluid With Sodium

NCT01547650

Other Diagnoses and Conditions

UNKNOWN

Fluid and Salt Restriction in Decompensated Heart Failure Patients

NCT01133236

Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Over-load

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHF peptide

Diuresis based on CHF-P

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

Based on clinical standard per clinician

Non CHF peptide

Diuresis based on clinical judgement without data for CHF-P

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

Based on clinical standard per clinician

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Furosemide

Based on clinical standard per clinician

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brand name: Lasix

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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