CARdiorenal REScue Study in Acute Decompensated Heart Failure: CARRESS
Overview
- Phase
- Phase 3
- Intervention
- Stepped pharmacologic care
- Conditions
- Heart Failure
- Sponsor
- Duke University
- Enrollment
- 188
- Locations
- 9
- Primary Endpoint
- Change in Serum Creatinine
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as cardiorenal syndrome, is a common complication of heart failure and causes further medical problems and need for hospitalization. While there are various effective treatments for heart failure, more research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.
Detailed Description
Heart failure is a common condition that affects approximately 5 million people in the United States, with 550,000 new cases diagnosed each year. Common symptoms of heart failure include swelling and fluid buildup in the legs, feet, and/or lungs; shortness of breath; coughing; elevated heart rate; change in appetite; and fatigue. If left untreated, the condition of the heart may deteriorate so far that the person undergoes ADHF. The number of hospitalizations attributed to ADHF has risen significantly, with many people readmitted soon after discharge because of recurring symptoms or further medical complications, such as cardiorenal syndrome. Current heart failure treatments focus on removing excess fluid buildup, often by increasing urination with diuretic medications or by draining directly from the veins. Direct drainage from the veins, also known as ultrafiltration, may be the more effective method for treating people with ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome. Participation in this study will last 60 days. All potential participants will undergo initial screening, which will include a medical history, physical exam, blood draws, measurements of fluid intake and urine output, and questionnaires. These same evaluations and procedures will be repeated at various points during the hospital stay. Eligible participants will be randomly assigned to receive standard medical drug therapy or fluid removal by ultrafiltration. Standard medical drug therapy will involve the intravenous delivery of diuretics and possibly other doctor-recommended medications. Ultrafiltration will involve intravenously removing blood, passing it through an ultrafiltration device, and then returning the blood to the participant. During ultrafiltration, participants will be treated with a blood thinner through the IV, as well. Follow-up assessments will occur at Days 30 and 60 after treatment. Follow-up assessments will include measurements of fluid intake, urine output, and vital signs; blood draws; physical exams; and questions about medications and status of recovery.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Stepped pharmacologic care
Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.
Intervention: Stepped pharmacologic care
Ultrafiltration
All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.
Intervention: Ultrafiltration
Outcomes
Primary Outcomes
Change in Serum Creatinine
Time Frame: Change from Baseline to Day 4
Change in Weight
Time Frame: Change from Baseline to Day 4
Secondary Outcomes
- Change in Glomerular Filtration Rate(Change from Baseline to Day 7)
- Change in Serum Creatinine(Change from Baseline to Day 7)
- Changes in Weight(Change from Baseline to Day 5)
- Change in Weight(Change from Baseline to Day 6)
- Cumulative Net Fluid Loss(Randomization through Day 7)
- Change in Blood Sodium Level(Baseline to Day 7/Discharge)
- Change in Blood Bicarbonate Level(Baseline to Day 7/Discharge)
- Change in Blood Potassium Level(Baseline to Day 7/Discharge)
- Change in Blood Urea Nitrogen/Urea(Baseline to Day 7/Discharge)
- Change in Blood Hemoglobin Level(Baseline to Day 7/Discharge)
- Change in Blood Cystatin C(Baseline to Day 60)
- Change in Uric Acid(Baseline to Day 4)
- Change in Blood N- Terminal Pro- BNP(Baseline to Day 4)
- Change in Plasma Renin Activity(Baseline to Day 60)
- Change in Blood High Sensitivity Troponin I(Baseline to Day 60)
- Change in Blood Aldosterone(Baseline to Day 60)
- Creatinine Change(Baseline to Day 30)
- Glomerular Filtration Rate Change(Baseline to Day 30)
- Dyspnea Visual Analog Scale(Change from Baseline to Day 4)
- Change in Global Visual Analog Scale(Baseline to Day 7/Discharge)
- Change in Dyspnea Visual Analog Scale(Baseline to Day 7/Discharge)
- Change in Furosemide-Equivalent Dose(Baseline to Day 60)
- Change in Blood Procollagen III N-terminal Propepide(Baseline to Day 60)
- Change in Blood Endothelin-1(Baseline to Day 60)
- Change in Blood High Sensitivity C-Reactive Protein(Baseline to Day 60)
- Change in Blood Carboxy-terminal Telopeptide of Collagen Type I(Baseline to Day 60)
- Change in Blood Uric Acid(Baseline to Day 60)
- Change in Blood N Terminal Pro-Natriuretic Peptide(Baseline to Day 7/Discharge)
- Weight Change(Baseline to Day 60)
- Best Available Serum Creatinine Change(Baseline to Day 60)
- Best Available Glomerular Filtration Rate Change(Baseline to Day 60)
- Change in Blood N Terminal Pro - B Natriuretic Peptides(Baseline to Day 60)