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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721421
First Posted: November 5, 2012
Last Update Posted: November 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
  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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01721421     History of Changes
Other Study ID Numbers: 11-LL-0505
First Submitted: November 1, 2012
First Posted: November 5, 2012
Last Update Posted: November 5, 2012
Last Verified: November 2012

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