Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease
Primary Purpose
End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
extended treatment time
Standard treatment time
Sponsored by
About this trial
This is an interventional health services research trial for End Stage Renal Disease focused on measuring haemodialysis, Crossover, Treatment time, nutritional status
Eligibility Criteria
Inclusion Criteria:
- Dialysis dependant for over 90 days
Exclusion Criteria:
- Haemodialysis for less than 90 days
- Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
- Patients with acute liver disease; History of underlying haematological condition;
- Elective planned change of renal replacement modality within the 12 months.
Sites / Locations
- Imperial College Healthcare NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extended Treatment time
standard treatment time
Arm Description
Extended treatment time of 6 hours
Standard Treatment time of 4 hours
Outcomes
Primary Outcome Measures
Serum albumin
Secondary Outcome Measures
Full Information
NCT ID
NCT01721421
First Posted
November 1, 2012
Last Updated
November 2, 2012
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT01721421
Brief Title
Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease
Official Title
Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Malnutrition-inflammation score
Dietary intake
Hand-Grip strength
Energy expenditure
Quality of life
Patient reported quality of life and
time to recovery from dialysis
Serum biomarkers
BNP
Troponin
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
haemodialysis, Crossover, Treatment time, nutritional status
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended Treatment time
Arm Type
Experimental
Arm Description
Extended treatment time of 6 hours
Arm Title
standard treatment time
Arm Type
Active Comparator
Arm Description
Standard Treatment time of 4 hours
Intervention Type
Other
Intervention Name(s)
extended treatment time
Intervention Description
patients receive extended dialysis treatment time time of 6 hours
Intervention Type
Other
Intervention Name(s)
Standard treatment time
Primary Outcome Measure Information:
Title
Serum albumin
Time Frame
baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dialysis dependant for over 90 days
Exclusion Criteria:
Haemodialysis for less than 90 days
Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
Patients with acute liver disease; History of underlying haematological condition;
Elective planned change of renal replacement modality within the 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seema Singh
Phone
+44 208 3835249
Email
s.singh11@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Choi, MBcHB PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seema Singh, MSc
Phone
+44 2083835249
Email
s.singh11@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Seema Singh, MSc
First Name & Middle Initial & Last Name & Degree
Charles Pusey
First Name & Middle Initial & Last Name & Degree
Peter Choi, PhD MD
12. IPD Sharing Statement
Learn more about this trial
Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease
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