More Frequent Dialysis (>3 Treatments Per Week)

Study Overview
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Brief Summary
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The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.

Official Title
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Study of Clinical Outcomes of More Frequent Hemodialysis

Conditions
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End Stage Renal Disease, Chronic Kidney Disease

Intervention / Treatment
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* Procedure: More frequent hemodialysis
* Procedure: More frequent hemodialysis
* Procedure: More frequent hemodialysis
* Procedure: More frequent hemodialysis
* Procedure: More frequent hemodialysis
* Procedure: More frequent hemodialysis
* Procedure: Conventional Hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports. 18 years of age. History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule. Plan to continue care and follow-up at the investigational site. Able to sign the informed consent and other relevant documents. Exclusion Criteria: History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months. Pregnancy. Intravenous drug abuser. Expects to receive a transplant or transfer to another facility within six months of entering the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Six Day per week short daily hemodialysis | Procedure: More frequent hemodialysis<br>* Six Day per week short daily hemodialysis<br>|
| Experimental: B<br>Six nights per week nocturnal hemodialysis | Procedure: More frequent hemodialysis<br>* Six nights per week nocturnal hemodialysis<br>|
| Experimental: C<br>Every other day short daily hemodialysis | Procedure: More frequent hemodialysis<br>* Every other day short daily hemodialysis<br>|
| Experimental: D<br>Every other night hemodialysis | Procedure: More frequent hemodialysis<br>* Every other night hemodialysis<br>|
| Experimental: E<br>5 days per week short daily hemodialysis | Procedure: More frequent hemodialysis<br>* 5 days per week short daily hemodialysis<br>|
| Experimental: F<br>5 nights per week hemodialysis | Procedure: More frequent hemodialysis<br>* 5 nights per week hemodialysis<br>|
| Active Comparator: G<br>Conventional three time per week short daily hemodialysis | Procedure: Conventional Hemodialysis<br>* 3 days per week short daily hemodialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization days per year |  | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Status measured by Subjective Global Assessment |  | Ongoing | 
| Anemia, measured by erythropoetin dose |  | Ongoing | 
| Control of hypertension, as measured by number of antihypertensive tablets taken per day |  | Ongoing | 
| Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day |  | Ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Adequacy, Frequency