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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01721421

Enrollment

Registered

2012-11-05

Start date

2011-09-30

Completion date

2015-02-28

Last updated

2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

haemodialysis, Crossover, Treatment time, nutritional status

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

Interventions

OTHERextended treatment time

patients receive extended dialysis treatment time time of 6 hours

OTHERStandard treatment time

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Serum albumin	baseline to 24 weeks

Countries

United Kingdom

Contacts

Primary ContactSeema Singh

s.singh11@imperial.ac.uk+44 208 3835249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026