Chronic Kidney InsufficiencyDIDITNCT02593526
Diuretic/Cool Dialysate Trial
A study testing Bumetanide and Cool Dialysate in people with Chronic Kidney Insufficiency, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Insufficiency
- What is being tested?
- Bumetanide and Cool Dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 27 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dialysis Clinic Inc. - Indian School
Albuquerque, New Mexico, 87106
About this study
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.
Read the 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
- Being tested
- Bumetanide, Cool Dialysate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BumetanideDrug
Also called Bumex
Diuretic
Cool DialysateOther
Cool dialysate (35°C)
| Study group | Role | What they receive |
|---|---|---|
| No Diuretic and 37°C dialysate | No intervention | Standard of care, no diuretic |
| No Diuretic and 35.5°C dialysate | Experimental | Cool dialysate only, no diuretic Receives: Other: Cool Dialysate |
| Diuretic and 37°C dialysate | Experimental | Isothermic dialysate (37°C) and bumetanide (diuretic) Receives: Drug: Bumetanide |
| Diuretic and 35.5°C dialysate | Experimental | Cool dialysate (35.5°C) and bumetanide (diuretic) Receives: Drug: Bumetanide; Other: Cool Dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJan 2017
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Responsible party
- Principal investigator, Mark Unruh, University of New Mexico
- Investigators
- Mark L Unruh, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593526
- Sponsor's protocol ID
- Diuretic/Cool Dialysate Trial
- Acronym
- DIDIT
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2015
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic/Cool Dialysate Trial
- ClinicalTrials.gov ID
- NCT02593526
- Acronym / sponsor ID
- DIDIT / Diuretic/Cool Dialysate Trial
- Conditions
- Chronic Kidney Insufficiency
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Posted 11 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Diuretic and 37°C dialysate | No intervention | –Standard of care, no diuretic |
| No Diuretic and 35.5°C dialysate | Experimental | Other: Cool DialysateCool dialysate only, no diuretic |
| Diuretic and 37°C dialysate | Experimental | Drug: BumetanideIsothermic dialysate (37°C) and bumetanide (diuretic) |
| Diuretic and 35.5°C dialysate | Experimental | Drug: Bumetanide, Other: Cool DialysateCool dialysate (35.5°C) and bumetanide (diuretic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BumetanideAlso: BumexDiuretic | Drug | Diuretic and 35.5°C dialysate, Diuretic and 37°C dialysate |
| Cool DialysateCool dialysate (35°C) | Other | Diuretic and 35.5°C dialysate, No Diuretic and 35.5°C dialysate |
Primary outcome
Slow the Rate of Residual Renal Function (RRF)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark L Unruh, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bumetanide and Cool Dialysate in people with Chronic Kidney Insufficiency, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow the Rate of Residual Renal Function (RRF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.