Protocolized Diuretic Strategy in Cardiorenal Failure
Status:
Terminated
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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 (using a guideline for adjusting doses based on measured urine output)
could improve health outcomes in patients with cardiorenal failure or cardiorenal syndrome
(combined heart and kidney failure) with edema (too much fluid in their arms, legs, and/or
lungs). Under usual care, these patients are treated with diuretics and other medications in
increasing doses, but not necessarily to maintain a specific amount of urine output per day.
Current heart failure (HF) treatment guidelines do not provide any standard protocol, or
guideline, for adjusting diuretic doses. At the point when kidney function worsens to the
degree that the kidneys are no longer able to respond to the medications used to remove
fluid, either ultrafiltration (UF) or dialysis (also called hemodialysis [HD]) is typically
started in order to remove fluid. In both UF and dialysis, excess fluid is removed from the
body by using a machine. In dialysis, both waste products and fluid are removed and
electrolyte abnormalities are corrected. In UF, only fluid is removed. Both procedures use
the same machine. This study will test whether a Protocolized Diuretic Strategy (ProDiuS), a
plan for adjusting diuretic doses based on measured urine output, will improve clinical care
for cardiorenal syndrome. Such a plan for adjusting diuretic doses is needed to improve
symptoms, decrease the length of hospital stays and rehospitalization rates, and improve
health-related quality of life (HRQOL) in cardiorenal syndrome patients.