Status:
TERMINATED
Protocolized Diuretic Strategy in Cardiorenal Failure
Lead Sponsor:
Kelly V. Liang, MD
Conditions:
Cardiac Failure
Renal Failure
Eligibility:
MALE
21+ years
Phase:
PHASE4
Brief Summary
This research study is a randomized clinical trial to evaluate if taking diuretics (medications that increase urine production and help with fluid removal from the body) in a standardized fashion (usi...
Detailed Description
Heart failure (HF) accounts for over 1 million hospital admissions annually in the United States and is a leading cause of disability and healthcare costs. Cardiorenal syndrome and worsening renal fun...
Eligibility Criteria
Inclusion
- Age ≥21 years
- History of heart failure (HF), with either left ventricular (LV) dysfunction (EF\<40%) or at least stage I diastolic or right ventricular (RV) dysfunction based on echocardiogram (ECHO) within the last year or diagnosis of HF by International Classification of Diseases (ICD-9)
- Evidence of renal dysfunction based on one of the following:
- Estimated glomerular filtration rate (GFR) 15-59 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation using serum creatinine (Cr) obtained within 6 months of admission
- Elevated Cr above upper limits of normal
- An increase in serum Cr of ≥0.3 mg/dL or ≥50% from baseline on admission or during diuretic therapy, with no alternative cause for worsening renal function, while demonstrating signs and symptoms of persistent volume overload occurring within 7 days before admission or during hospitalization
- Evidence of volume overload by clinical and/or radiographic features, with at least 2 of the following: 1) peripheral edema ≥2+; 2) jugular venous distension ≥7 cm; 3) radiographic pulmonary edema or pleural effusion; 4) enlarged liver or ascites; 5) pulmonary rales, paroxysmal nocturnal dyspnea, or orthopnea; 6) elevated brain natriuretic peptide (BNP) level; 7) documentation of elevated right heart filling pressures by pulmonary artery catheter or right heart catheterization
Exclusion
- Use of inotropes (at time of screening)
- Acute indications for hemodialysis (HD) (e.g., severe hyperkalemia, metabolic acidosis, uremic signs or symptoms, pericardial friction rub)
- Specific forms of HF by chart diagnoses:
- Congenital heart disease
- Primary valvular heart disease due to severe valvular stenosis or acute severe valvular regurgitation or valvular disease requiring immediate surgical repair
- Infiltrative cardiomyopathies
- Pulmonary hypertension (PH) as defined by World Health Organization (WHO) group I and WHO group IV - Prior use of ultrafiltration (UF) or HD in the 3 months preceding hospitalization
- End-stage renal disease (ESRD) requiring chronic dialysis or estimated GFR \<15 mL/min/1.73 m2 by MDRD equation (i.e., pre-existing ESRD)
- Prior cardiac or kidney transplantation
- Intravascular volume depletion based on clinical assessment
- Cardiogenic shock and/or systolic blood pressure (SBP) \<90 mmHg
- Unstable coronary disease or acute coronary syndrome within 1 month of admission
- Alternative explanation for worsening renal function (e.g., obstructive nephropathy, contrast-induced nephropathy, acute tubular necrosis, intrinsic renal diseases)
- Life expectancy \< 3 months due to other chronic health conditions (e.g., end-stage liver disease, pulmonary disease, malignancy, etc.)
- Psychiatric disorder requiring admission to a psychiatric hospital during HF admission
- Previous enrollment in this trial or other diuretic or UF trial in the prior 3 months
- Expected geographic unavailability for 3 months following hospital admission
- Pregnancy
- Inability to provide informed consent
- Physician's assessment that use of the protocol could be unsafe or lead to adverse consequences for the patient
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01921829
Start Date
November 1 2013
End Date
November 1 2015
Last Update
August 21 2017
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213