NCT01721421

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. 1.Malnutrition-inflammation score
  2. 2.Dietary intake
  3. 3.Hand-Grip strength
  4. 4.Energy expenditure
  5. 5.Patient reported quality of life and
  6. 6.time to recovery from dialysis
  7. 7.BNP
  8. 8.Troponin
  9. 9.MCP-1

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 5, 2012

Status Verified

November 1, 2012

Enrollment Period

2.5 years

First QC Date

November 1, 2012

Last Update Submit

November 2, 2012

Conditions

End Stage Renal Disease

Keywords

haemodialysisCrossoverTreatment timenutritional status

Outcome Measures

Primary Outcomes (1)

  • Serum albumin

    baseline to 24 weeks

Study Arms (2)

Extended Treatment time

EXPERIMENTAL

Extended treatment time of 6 hours

Other: extended treatment timeOther: Standard treatment time

standard treatment time

ACTIVE COMPARATOR

Standard Treatment time of 4 hours

Other: extended treatment timeOther: Standard treatment time

Interventions

extended treatment timeOTHER

patients receive extended dialysis treatment time time of 6 hours

Extended Treatment timestandard treatment time
Standard treatment timeOTHER
Extended Treatment timestandard treatment time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dialysis dependant for over 90 days

You may not qualify if:

  • Haemodialysis for less than 90 days
  • Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
  • Patients with acute liver disease; History of underlying haematological condition;
  • Elective planned change of renal replacement modality within the 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Choi, MBcHB PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seema Singh

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 5, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

February 1, 2015

Last Updated

November 5, 2012

Record last verified: 2012-11

Locations

GB(1)