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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Imperial College London.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: November 1, 2012
Last updated: November 2, 2012
Last verified: November 2012

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

Condition Intervention
End Stage Renal Disease Other: extended treatment time Other: Standard treatment time

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis

Resource links provided by NLM:

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Serum albumin [ Time Frame: baseline to 24 weeks ]

Estimated Enrollment: 52
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended Treatment time
Extended treatment time of 6 hours
Other: extended treatment time
patients receive extended dialysis treatment time time of 6 hours
Other: Standard treatment time
Active Comparator: standard treatment time
Standard Treatment time of 4 hours
Other: extended treatment time
patients receive extended dialysis treatment time time of 6 hours
Other: Standard treatment time


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01721421

Contact: Seema Singh +44 208 3835249

United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Seema Singh, MSc    +44 2083835249   
Sub-Investigator: Seema Singh, MSc         
Principal Investigator: Charles Pusey         
Principal Investigator: Peter Choi, PhD MD         
Sponsors and Collaborators
Imperial College London
Principal Investigator: Peter Choi, MBcHB PhD Imperial College London
  More Information

Responsible Party: Imperial College London Identifier: NCT01721421     History of Changes
Other Study ID Numbers: 11-LL-0505
Study First Received: November 1, 2012
Last Updated: November 2, 2012

Keywords provided by Imperial College London:
Treatment time
nutritional status

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on September 19, 2017