NCT02063776

Brief Summary

Children on conventional haemodialysis (HD) die of heart disease. Also, they can be malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and children show improved growth, but mechanisms are not understood. We will follow children in the UK and Europe to compare HDF and HD. We will monitor growth, heart and blood vessel scans, blood markers and quality of life. If the 3H (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may be adopted as the preferred type of dialysis in children.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

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

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

February 13, 2014

Last Update Submit

February 21, 2018

Conditions

ChildrenHaemodialysisHaemodiafiltration

Keywords

Haemodiafiltration (HDF)Haemodialysis (HD)ChildrenCarotid intima media thicknessPulse wave velocityHeight standard deviation score

Outcome Measures

Primary Outcomes (2)

  • 1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS)

    12 months

  • Change in height SDS

    12 months

Secondary Outcomes (3)

  • For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status

    6 months

  • For cardiovascular status 1. 24-hour mean arterial BP SDS 2. Left ventricular mass index 3. Pulse wave velocity SDS 4. Biomarkers of cardiovascular disease

    12 months

  • Quality of life (QoL) questionnaires

    12 months

Study Arms (2)

Children on HDF

Children on conventional HD

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* HDF patients will be compared with age-matched HD patients in a 1:1 study design. * Children will be recruited from paediatric dialysis units within the UK and also centres in Europe, through the 4C-study.

You may qualify if:

  • All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)
  • Age-matched HD patients
  • Prevalent HDF and HD patients must achieve a single pool Kt/v\>1.2 in the month preceding recruitment

You may not qualify if:

  • \. Children in whom a living donor kidney transplant is planned within 6-months of start of dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rukshana Shroff

London, WC1N 3JH, United Kingdom

Location

Related Publications (2)

  • Shroff R, Bayazit A, Stefanidis CJ, Askiti V, Azukaitis K, Canpolat N, Agbas A, Anarat A, Aoun B, Bakkaloglu S, Bhowruth D, Borzych-Duzalka D, Bulut IK, Buscher R, Dempster C, Duzova A, Habbig S, Hayes W, Hegde S, Krid S, Licht C, Litwin M, Mayes M, Mir S, Nemec R, Obrycki L, Paglialonga F, Picca S, Ranchin B, Samaille C, Shenoy M, Sinha M, Smith C, Spasojevic B, Vidal E, Vondrak K, Yilmaz A, Zaloszyc A, Fischbach M, Schaefer F, Schmitt CP. Effect of haemodiafiltration vs conventional haemodialysis on growth and cardiovascular outcomes in children - the HDF, heart and height (3H) study. BMC Nephrol. 2018 Aug 10;19(1):199. doi: 10.1186/s12882-018-0998-y.

    PMID: 30097064DERIVED

  • Agbas A, Canpolat N, Caliskan S, Yilmaz A, Ekmekci H, Mayes M, Aitkenhead H, Schaefer F, Sever L, Shroff R. Hemodiafiltration is associated with reduced inflammation, oxidative stress and improved endothelial risk profile compared to high-flux hemodialysis in children. PLoS One. 2018 Jun 18;13(6):e0198320. doi: 10.1371/journal.pone.0198320. eCollection 2018.

    PMID: 29912924DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum only

Study Officials

  • Rukshana C Shroff, MD FRCPCH PhD

    Great Ormond Street Hospital for Children NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2017

Study Completion

December 1, 2019

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

GB(1)