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

Overview

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

Full Title of Study: “Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Interventions

  • Other: extended treatment time
    • patients receive extended dialysis treatment time time of 6 hours
  • Other: Standard treatment time

Arms, Groups and Cohorts

  • Experimental: Extended Treatment time
    • Extended treatment time of 6 hours
  • Active Comparator: standard treatment time
    • Standard Treatment time of 4 hours

Clinical Trial Outcome Measures

Primary Measures

  • Serum albumin
    • Time Frame: baseline to 24 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Dialysis dependant for over 90 days Exclusion Criteria:

1. Haemodialysis for less than 90 days 2. Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus 3. Patients with acute liver disease; History of underlying haematological condition; 4. Elective planned change of renal replacement modality within the 12 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Imperial College London
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Choi, MBcHB PhD, Principal Investigator, Imperial College London
  • Overall Contact(s)
    • Seema Singh, +44 208 3835249, s.singh11@imperial.ac.uk

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