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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01721421
• Other study ID #: 11-LL-0505
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2012
• Last updated: November 2, 2012
• Start date: September 2011
• Est. completion date: February 2015

Study information

• Verified date: November 2012
• Source: Imperial College London
• Contact: Seema Singh
• Phone: +44 208 3835249
• Email: s.singh11[@]imperial.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• extended treatment time
patients receive extended dialysis treatment time time of 6 hours
• Standard treatment time

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum albumin		baseline to 24 weeks	No