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

NCT ID: NCT01721421

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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End Stage Renal Disease

Keywords

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haemodialysis Crossover Treatment time nutritional status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Extended Treatment time

Extended treatment time of 6 hours

Group Type EXPERIMENTAL

extended treatment time

Intervention Type OTHER

patients receive extended dialysis treatment time time of 6 hours

Standard treatment time

Intervention Type OTHER

standard treatment time

Standard Treatment time of 4 hours

Group Type ACTIVE_COMPARATOR

extended treatment time

Intervention Type OTHER

patients receive extended dialysis treatment time time of 6 hours

Standard treatment time

Intervention Type OTHER

Interventions

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extended treatment time

patients receive extended dialysis treatment time time of 6 hours

Intervention Type OTHER

Standard treatment time

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Choi, MBcHB PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Seema Singh

Role: CONTACT

Phone: +44 208 3835249

Email: [email protected]

Facility Contacts

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Seema Singh, MSc

Role: primary

Other Identifiers

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11-LL-0505

Identifier Type: -

Identifier Source: org_study_id