NCT02044614

Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Davita Clinical Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. To assess the feasibility and safety of applying a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to an ongoing regimen of thrice-weekly in-center hemodialysis. Hypothesis: Icodextrin-based peritoneal dialysis can be safely and feasibly implemented in the context of ongoing thrice-weekly in-center hemodialysis. 2. To measure the effects of a 12-week course of adjuvant low-frequency icodextrin-based peritoneal dialysis to ongoing thrice-weekly maintenance hemodialysis on: inter-hemodialytic weight gain, achievable hemodialytic dry weight, total body water, ambulatory blood pressure, serum phosphorus, and pre-to-post hemodialysis changes in serum potassium and pH, and Kidney Disease Quality of Life-SF physical functioning, energy fatigue, and general health scores. Hypotheses: Addition of adjuvant icodextrin-based peritoneal dialysis will: 1. reduce inter-hemodialytic weight gain\* 2. enable achievement of lower hemodialytic dry weight 3. reduce total body water 4. improve ambulatory blood pressure control 5. reduce serum phosphorus 6. minimize per-hemodialytic changes in serum potassium and pH 7. have favorable effects on indices of physical function and global health * Indicates co-primary outcomes.

Conditions

• Functionally Anuric
• Hemodialysis/Peritoneal Dialysis

Interventions

Type	Name	Description
OTHER	Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-01-24
• Last updated: 2016-08-17