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

NCT01721421 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-11-05

No results posted yet for this study

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

Conditions

Interventions

OTHER

extended treatment time

patients receive extended dialysis treatment time time of 6 hours

OTHER

Standard treatment time

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Peter Choi, MBcHB PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-03-31
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01721421 on ClinicalTrials.gov