Diuretic/Cool Dialysate Trial

NCT02593526 | Terminated Results

• 1 other identifier: Diuretic/Cool Dialysate Trial
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (4)

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

Other: Cool Dialysate

Diuretic and 37°C dialysate

EXPERIMENTAL

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

Drug: Bumetanide

Diuretic and 35.5°C dialysate

EXPERIMENTAL

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

Drug: Bumetanide; Other: Cool Dialysate

Interventions

Bumetanide DRUG

Diuretic

Also known as: Bumex

Diuretic and 35.5°C dialysate; Diuretic and 37°C dialysate

Cool Dialysate OTHER

Cool dialysate (35°C)

Diuretic and 35.5°C dialysate; No Diuretic and 35.5°C dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• Dialysis Clinic, Inc.: collaborator

Study Sites (1)

Dialysis Clinic Inc. - Indian School

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Bumetanide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Mark Unruh
• Organization: UNewMexico

MLUnruh@salud.unm.edu

5052728800

Study Officials

• Mark L Unruh, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine, Division of Nephrology Chief

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 2, 2015
• Study Start: January 1, 2017
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-12

Locations

US (1)