Trial Outcomes & Findings for Diuretic/Cool Dialysate Trial (NCT NCT02593526)

Last Updated: 2024-01-11

Results Overview

To be randomized Adequate RRF has to be determined in the first 24 hour collection (ml/min). If randomized RRF will be collected day 0 pre-dose intervention and Month 4 and 6 of intervention (3 collections) to determine if the rate was slowed. RRF is standard of care assessment for patients on dialysis for quality of life and survival.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2024-01-11

Participant Flow

Participants were recruited from one academic medical center between December 15, 2015 and May 27, 2022, with the first participant being enrolled January 2017.

Of the 11 enrolled participants only 1 met randomization criteria and was randomized to treatment.

Participant milestones

Participant milestones
Measure	No Diuretic and 37°C Dialysate Standard of care, no diuretic	No Diuretic and 35.5°C Dialysate Cool dialysate only, no diuretic Cool Dialysate: Cool dialysate (35°C)	Diuretic and 37°C Dialysate Isothermic dialysate (37°C) and bumetanide (diuretic) Bumetanide: Diuretic	Diuretic and 35.5°C Dialysate Cool dialysate (35.5°C) and bumetanide (diuretic) Bumetanide: Diuretic Cool Dialysate: Cool dialysate (35°C)
Overall Study STARTED	0	0	0	1
Overall Study COMPLETED	0	0	0	1
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diuretic/Cool Dialysate Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Diuretic and 37°C Dialysate Standard of care, no diuretic	No Diuretic and 35.5°C Dialysate Cool dialysate only, no diuretic Cool Dialysate: Cool dialysate (35°C)	Diuretic and 37°C Dialysate Isothermic dialysate (37°C) and bumetanide (diuretic) Bumetanide: Diuretic	Diuretic and 35.5°C Dialysate n=1 Participants Cool dialysate (35.5°C) and bumetanide (diuretic) Bumetanide: Diuretic Cool Dialysate: Cool dialysate (35°C)	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	—	—	—	1 Participants n=4 Participants	1 Participants n=21 Participants
Age, Categorical >=65 years	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	—	—	—	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	—	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	—	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	—	—	—	1 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only one participant met criteria for randomization.

Outcome measures

Outcome measures
Measure	No Diuretic and 37°C Dialysate Standard of care, no diuretic	No Diuretic and 35.5°C Dialysate Cool dialysate only, no diuretic Cool Dialysate: Cool dialysate (35°C)	Diuretic and 37°C Dialysate Isothermic dialysate (37°C) and bumetanide (diuretic) Bumetanide: Diuretic	Diuretic and 35.5°C Dialysate n=1 Participants Cool dialysate (35.5°C) and bumetanide (diuretic) Bumetanide: Diuretic Cool Dialysate: Cool dialysate (35°C)
Slow the Rate of Residual Renal Function (RRF)	0 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

No Diuretic and 37°C Dialysate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Diuretic and 35.5°C Dialysate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diuretic and 37°C Dialysate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diuretic and 35.5°C Dialysate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Unruh

UNewMexico

Phone: 5052728800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place