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

Not Applicable

• Conditions: End Stage Renal Disease
• Interventions: Other: extended treatment time; Other: Standard treatment time

• Registration Number: NCT01721421
• Lead Sponsor: Imperial College London

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

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Status Verified: 2012-11
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Study First Posted: 2012-11-04
• Last Update Posted: 2012-11-04
• Primary Completion: 2014-03
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Dialysis dependant for over 90 days

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extended Treatment time	extended treatment time	Extended treatment time of 6 hours
Extended Treatment time	Standard treatment time	Extended treatment time of 6 hours
standard treatment time	extended treatment time	Standard Treatment time of 4 hours
standard treatment time	Standard treatment time	Standard Treatment time of 4 hours

Primary Outcome Measures

Name	Time	Method
Serum albumin	baseline to 24 weeks

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom