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

This study is currently recruiting participants.
Verified November 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01721421
First received: November 1, 2012
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Serum albumin [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721421

Contacts
Contact: Seema Singh +44 208 3835249 s.singh11@imperial.ac.uk

Locations
United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W12 0HS
Contact: Seema Singh, MSc     +44 2083835249     s.singh11@imperial.ac.uk    
Sub-Investigator: Seema Singh, MSc            
Principal Investigator: Charles Pusey            
Principal Investigator: Peter Choi, PhD MD            
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Peter Choi, MBcHB PhD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01721421     History of Changes
Other Study ID Numbers: 11-LL-0505
Study First Received: November 1, 2012
Last Updated: November 2, 2012
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by Imperial College London:
haemodialysis
Crossover
Treatment time
nutritional status

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013