Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease

Study Overview
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Brief Summary
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Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks. Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period. Primary outcome measure 1]Serum albumin Secondary outcome measures Nutritional status Malnutrition-inflammation score Dietary intake Hand-Grip strength Energy expenditure Quality of life Patient reported quality of life and time to recovery from dialysis Serum biomarkers BNP Troponin MCP-1 Others 24- hour Ambulatory blood pressure 24-hour accelerometer Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks

Official Title
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Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: extended treatment time
* Other: Standard treatment time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dialysis dependant for over 90 days Exclusion Criteria: Haemodialysis for less than 90 days Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus Patients with acute liver disease; History of underlying haematological condition; Elective planned change of renal replacement modality within the 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Treatment time<br>Extended treatment time of 6 hours | Other: extended treatment time<br>* patients receive extended dialysis treatment time time of 6 hours<br>Other: Standard treatment time<br> <br> |
| Active Comparator: standard treatment time<br>Standard Treatment time of 4 hours | Other: extended treatment time<br>* patients receive extended dialysis treatment time time of 6 hours<br>Other: Standard treatment time<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin |  | baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemodialysis, Crossover, Treatment time, nutritional status