End Stage Renal Disease Clinical Trial
Official title:
Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
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
1. Malnutrition-inflammation score
2. Dietary intake
3. Hand-Grip strength
4. Energy expenditure
Quality of life
1. Patient reported quality of life and
2. time to recovery from dialysis
Serum biomarkers
1. BNP
2. Troponin
3. 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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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