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Diuretic/Cool Dialysate Trial (DIDIT)

Primary Purpose

Chronic Kidney Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bumetanide
Cool Dialysate
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dialysis Clinic Inc. - Indian School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

No Diuretic and 37°C dialysate

No Diuretic and 35.5°C dialysate

Diuretic and 37°C dialysate

Diuretic and 35.5°C dialysate

Arm Description

Standard of care, no diuretic

Cool dialysate only, no diuretic

Isothermic dialysate (37°C) and bumetanide (diuretic)

Cool dialysate (35.5°C) and bumetanide (diuretic)

Outcomes

Primary Outcome Measures

Change in residual kidney function over 6 months
Association of HD frequency with inflammation
Blood and urine labs: CRP, IL-6, IL-1β, TNF-α, β2M, micro-RNA, albumin and urinary micro-RNA, respectively, will be reviewed in association with their collective relationship to indications of HD frequency with inflammation.
Acute Kidney Injury (AKI) markers
Blood and urine labs: β2Μ, cystatin C, creatinine, micro-RNA, NGAL, KIM-1 and urinary NGAL, urinary KIM-1, urinary HGF, micro-RNA, cystatin C, creatinine, respectively, will be reviewed in association with their collective relationship to indications of acute kidney injury.

Secondary Outcome Measures

Changes in health reported quality of life (HRQOL) within the first six months
Changes in physical, mental, emotional, fatigue and social well-being symptoms will be monitored through the Dialysis Symtoms Index and PROMIS-57 questionnaires
Time to first non-access hospitalization

Full Information

First Posted
October 20, 2015
Last Updated
May 24, 2023
Sponsor
University of New Mexico
Collaborators
Dialysis Clinic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02593526
Brief Title
Diuretic/Cool Dialysate Trial
Acronym
DIDIT
Official Title
Diuretic/Cool Dialysate Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
Dialysis Clinic, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Diuretic and 37°C dialysate
Arm Type
No Intervention
Arm Description
Standard of care, no diuretic
Arm Title
No Diuretic and 35.5°C dialysate
Arm Type
Experimental
Arm Description
Cool dialysate only, no diuretic
Arm Title
Diuretic and 37°C dialysate
Arm Type
Experimental
Arm Description
Isothermic dialysate (37°C) and bumetanide (diuretic)
Arm Title
Diuretic and 35.5°C dialysate
Arm Type
Experimental
Arm Description
Cool dialysate (35.5°C) and bumetanide (diuretic)
Intervention Type
Drug
Intervention Name(s)
Bumetanide
Other Intervention Name(s)
Bumex
Intervention Description
Diuretic
Intervention Type
Other
Intervention Name(s)
Cool Dialysate
Intervention Description
Cool dialysate (35°C)
Primary Outcome Measure Information:
Title
Change in residual kidney function over 6 months
Time Frame
6 months
Title
Association of HD frequency with inflammation
Description
Blood and urine labs: CRP, IL-6, IL-1β, TNF-α, β2M, micro-RNA, albumin and urinary micro-RNA, respectively, will be reviewed in association with their collective relationship to indications of HD frequency with inflammation.
Time Frame
6 months
Title
Acute Kidney Injury (AKI) markers
Description
Blood and urine labs: β2Μ, cystatin C, creatinine, micro-RNA, NGAL, KIM-1 and urinary NGAL, urinary KIM-1, urinary HGF, micro-RNA, cystatin C, creatinine, respectively, will be reviewed in association with their collective relationship to indications of acute kidney injury.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in health reported quality of life (HRQOL) within the first six months
Description
Changes in physical, mental, emotional, fatigue and social well-being symptoms will be monitored through the Dialysis Symtoms Index and PROMIS-57 questionnaires
Time Frame
6 months
Title
Time to first non-access hospitalization
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark L Unruh, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dialysis Clinic Inc. - Indian School
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

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Diuretic/Cool Dialysate Trial

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