The objective of the study is to determine if the addition of peritoneal ultrafiltration to
standard therapy in treatment-resistant severe heart failure patients will improve fluid
balance and functional capacity such that they will spend less time in the hospital and have
an improved ambulatory quality of life in comparison to patients who remain on standard
therapy alone.
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Completed
Baxter Healthcare Corporation
Phase 3
2008-04-01
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal)
in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated
Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the
magnitude of change from the baseline value in the HbA1c levels.
Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs
Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower
glycemic-control medication requirements, decreased incidence of severe hypoglycemic events
requiring medical intervention, improved metabolic control, nutritional status, and Quality
of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs
Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be
assessed.
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