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Diuretic/Cool Dialysate Trial (DIDIT)

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ClinicalTrials.gov Identifier: NCT02593526
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Dialysis Clinic, Inc.
Information provided by (Responsible Party):
Mark Unruh, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Insufficiency Drug: Bumetanide Other: Cool Dialysate Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diuretic/Cool Dialysate Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bumetanide

Arm Intervention/treatment
No Intervention: No Diuretic and 37°C dialysate
Standard of care, no diuretic
Experimental: No Diuretic and 35.5°C dialysate
Cool dialysate only, no diuretic
Other: Cool Dialysate
Cool dialysate (35°C)

Experimental: Diuretic and 37°C dialysate
Isothermic dialysate (37°C) and bumetanide (diuretic)
Drug: Bumetanide
Diuretic
Other Name: Bumex

Experimental: Diuretic and 35.5°C dialysate
Cool dialysate (35.5°C) and bumetanide (diuretic)
Drug: Bumetanide
Diuretic
Other Name: Bumex

Other: Cool Dialysate
Cool dialysate (35°C)




Primary Outcome Measures :
  1. Change in residual kidney function over 6 months [ Time Frame: 6 months ]
  2. Association of HD frequency with inflammation [ Time Frame: 6 months ]
    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.

  3. Acute Kidney Injury (AKI) markers [ Time Frame: 6 months ]
    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 :
  1. Changes in health reported quality of life (HRQOL) within the first six months [ Time Frame: 6 months ]
    Changes in physical, mental, emotional, fatigue and social well-being symptoms will be monitored through the Dialysis Symtoms Index and PROMIS-57 questionnaires

  2. Time to first non-access hospitalization [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593526


Contacts
Contact: Mark L Unruh, MD 5052720407

Locations
United States, New Mexico
Dialysis Clinic Inc. - Indian School Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Christopher Zima    505-272-6603    CPZima@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
Dialysis Clinic, Inc.
Investigators
Principal Investigator: Mark L Unruh, MD University of New Mexico

Responsible Party: Mark Unruh, Department of Internal Medicine, Division of Nephrology Chief, University of New Mexico
ClinicalTrials.gov Identifier: NCT02593526     History of Changes
Other Study ID Numbers: Diuretic/Cool Dialysate Trial
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Diuretics
Bumetanide
Dialysis Solutions
Natriuretic Agents
Physiological Effects of Drugs
Pharmaceutical Solutions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action