Fluid Over-load
Conditions
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.
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.
Interventions
DRUGFurosemide
Based on clinical standard per clinician
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
1. Recent myocardial infarction (within 3 months). 2. ASA class 4 and more. 3. Emergency surgeries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHF Peptide Diuresis based on CHF-P
Furosemide: Based on clinical standard per clinician | 25 |
| Non CHF Peptide Diuresis based on clinical judgement without data for CHF-P | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | CHF Peptide | Non CHF Peptide | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 10 | 70 years STANDARD_DEVIATION 9 | 70 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 4 / 25 |
Outcome results
Primary
Length of Stay
The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay
Time frame: From date of admission until date of discharge, assessed up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHF Peptide | Length of Stay | 4 days | Standard Deviation 3 |
| Non CHF Peptide | Length of Stay | 6 days | Standard Deviation 5 |