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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014