Chronic Kidney Insufficiency
Conditions
Brief 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.
Interventions
DRUGBumetanide
Diuretic
OTHERCool Dialysate
Cool dialysate (35°C)
Sponsors
Dialysis Clinic, Inc.
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary speaking language is English. * Patient is HD naïve (Patient may still enroll as long as no more than 12 weeks of in-center HD have been performed prior to randomization) * HD takes place at one of the participating Dialysis Clinic Inc. (DCI) sites during the data collection period. * Daily urine output is over 500ml. * Patients must be willing and able to sign the consent form.
Exclusion criteria
* RRF \<5 mL/min/1.73 m2 as determined by iohexol GFR measurement. * Allergy or contraindication to iohexol and/or bumetanide. * Has been undergoing dialysis for more than 12 weeks. * Expectation that native kidneys will recover. * History of poor adherence to treatment. * Unable to verbally communicate in English. * Requires more than 3 HD treatments per week due to medical co-morbidity (such as, but not limited to: severe volume overload requiring frequent HD e.g. in systemic oxalosis, or requiring total parenteral nutrition). * Scheduled for living donor kidney transplant in the next 6 months. * Intention to change to peritoneal dialysis, or home HD in the next 6 months. * Plan to relocate to another center within the next 7-8 months. * Expected geographic unavailability at a participating HD unit for \>2 consecutive weeks or \>4 weeks total during the next 6 months (excluding unavailability due to hospitalizations) * Post kidney transplantation * Currently in an acute or chronic care hospital * Life expectancy \<6 months or intention to withdraw dialysis therapy within 6 months. * Current pregnancy * Actively planning to become pregnant in the next 8 months * Nursing mothers * Current use of investigational drugs * Participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial * Unable or unwilling to follow the study protocol for any reason (including mental incompetence) * Unable or unwilling to provide informed consent or sign IRB-approved consent form. The following special populations will not be included in this study: * Patients who are too infirm or lack the capacity to meaningfully participate in medical decisions and to sign the informed consent. * Children and adolescents constitute \<2% of the dialysis population, and our preliminary survey of the study sites found no children and adolescents were active patients. In any case, the renal and other physical factors of children and adolescents with ESRD are not directly comparable to those of adults. * Prisoners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow the Rate of Residual Renal Function (RRF) | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one academic medical center between December 15, 2015 and May 27, 2022, with the first participant being enrolled January 2017.
Pre-assignment details
Of the 11 enrolled participants only 1 met randomization criteria and was randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| No Diuretic and 37°C Dialysate Standard of care, no diuretic | 0 |
| No Diuretic and 35.5°C Dialysate Cool dialysate only, no diuretic
Cool Dialysate: Cool dialysate (35°C) | 0 |
| Diuretic and 37°C Dialysate Isothermic dialysate (37°C) and bumetanide (diuretic)
Bumetanide: Diuretic | 0 |
| Diuretic and 35.5°C Dialysate Cool dialysate (35.5°C) and bumetanide (diuretic)
Bumetanide: Diuretic
Cool Dialysate: Cool dialysate (35°C) | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Diuretic and 35.5°C Dialysate | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Slow the Rate of Residual Renal Function (RRF)
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.
Time frame: 6 months
Population: Only one participant met criteria for randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Diuretic and 37°C Dialysate | Slow the Rate of Residual Renal Function (RRF) | 0 Participants |
| No Diuretic and 35.5°C Dialysate | Slow the Rate of Residual Renal Function (RRF) | 0 Participants |
| Diuretic and 37°C Dialysate | Slow the Rate of Residual Renal Function (RRF) | 0 Participants |
| Diuretic and 35.5°C Dialysate | Slow the Rate of Residual Renal Function (RRF) | 1 Participants |