NCT02593526

Diuretic/Cool Dialysate Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed pilot study challenges the current widespread paradigm of discontinuing loop diuretics when initiating chronic HD and/or maintaining the dialysate at a constant temperature of 37 °C for all patients.

Detailed description

This pilot/feasibility RCT will recruit for 18 months and demonstrate the feasibility and safety of performing a large scale study of diuretic use and/or cool dialysate examining recruitment, retention, and key outcomes. This study will further assess whether the use of a diuretic compared to non-use of a diuretic and/or the use of cool dialysate (35.5 ºC) compared to 37 ºC for up to 6 months will improve residual renal function (RRF), improve health reported quality of life (HRQOL) and reduce hospitalizations by randomizing 20 dialysis-naïve patients (started chronic HD in the last three months) from DCI centers in the greater Albuquerque area, to either bumetanide and cool dialysate randomized in a two-by-two factorial distribution.

Conditions

• Chronic Kidney Insufficiency

Interventions

Type	Name	Description
DRUG	Bumetanide	Diuretic
OTHER	Cool Dialysate	Cool dialysate (35°C)

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2015-11-02
• Last updated: 2024-01-11
• Results posted: 2024-01-11

Locations

1 site across 1 country: United States