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

Imperial College London

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Other: Standard treatment time; Other: extended treatment time

Study type: Interventional

Funder types: Other

Identifiers

NCT01721421

11-LL-0505

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Extended Treatment time

Experimental group

Description:

Extended treatment time of 6 hours

Treatment:

Other: extended treatment time

Other: Standard treatment time

standard treatment time

Active Comparator group

Description:

Standard Treatment time of 4 hours

Treatment:

Other: extended treatment time

Other: Standard treatment time