Dialysis-Less Frequently In The Elderly

NCT03787719 | Completed

• 1 other identifier: 6021932
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Thrice-weekly dialysis is the accepted standard of care for hemodialysis (HD) patients. Observational studies suggest that elderly HD patients do as well and have better quality of life with less dialysis (ie twice-weekly). We propose a single-center pilot study of 40 patients to determine the feasibility of a large randomized controlled trial (RCT) designed to determine the impact of HD frequency on well-being in new HD patients above the age of 70. The primary outcomes will be metrics of feasibility and safety. We hypothesize that an adequately powered RCT that will determine whether elderly patients who dialyze twice weekly have improved well-being compared to thrice-weekly is feasible

Conditions

Dialysis; End Stage Renal Disease; Hemodialysis

Keywords

Twice weekly dialysis; Thrice weekly dialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Successful recruitment will be defined as \>3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.

  1 year

• percent of prescribed treatments completed by patient

  Successful adherence will be defined as =\> 90% of intervention being adhered to.

  1 year

• Loss to trial completion

  Successful loss to trial completion will be defined as = \>50% of randomized patients completing the 12 month trial. Based on our data, the anticipated reasons for loss to trial completion will be death and moving away from the study center.

  1 year

• Percent of weekly potassium values falling within normal range.

  Potassium will be measured every week for the duration of the study.

  1 year

• Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight

  Prescribed and acheived post HD weight will be recorded weekly.

  1 year

Secondary Outcomes (1)

• Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R)

  1 year

Study Arms (2)

Twice per week dialysis

EXPERIMENTAL

Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).

Other: Twice per week dialysis

Thrice per week dialysis

NO INTERVENTION

Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)

Interventions

Twice per week dialysis OTHER

Twice-weekly 4 hour dialysis treatment

Twice per week dialysis

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Greater than equal 70 years old, planned ongoing in-center HD treatment
• Incident HD patient and still alive 7 weeks post HD initiation
• Patient or substitute decision maker provide informed consent

You may not qualify if:

• Significant barriers to ascertainment of the patient-reported experience measures
• Patient currently admitted to hospital without Alternate Level of Care designation
• Patient non-adherent to dialysis prescription

Sponsors & Collaborators

• Dr. Christine White: lead

Study Sites (1)

Kingston Health Sciences Centre (KHSC)

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single center pilot study

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 26, 2018
• Study Start: June 27, 2018
• Primary Completion: September 11, 2023
• Study Completion: November 9, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CA (1)