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

November 2, 2012 updated by: Imperial College London

Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Sub-Investigator:
          • Seema Singh, MSc
        • Principal Investigator:
          • Charles Pusey
        • Principal Investigator:
          • Peter Choi, PhD MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum albumin
Time Frame: baseline to 24 weeks
baseline to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Peter Choi, MBcHB PhD, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

November 1, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 4, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-LL-0505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on extended treatment time

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe