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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02063776
Other study ID # 13NU02
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 13, 2014
Last updated February 21, 2018
Start date February 2014
Est. completion date December 2019

Study information

Verified date February 2018
Source Great Ormond Street Hospital for Children NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Background: Children on conventional haemodialysis (HD) have a 1000-fold higher mortality than their healthy peers and can have malnutrition and growth retardation. Haemodiafiltration (HDF) achieves better clearance of uraemic solutes across a wide molecular-weight range and performs greater ultrafiltration than conventional HD. Randomised controlled trials in adults have shown 35-45% improved survival and reduced cardiovascular mortality on HDF with high convection volumes. Excellent catch-up growth has been demonstrated in children on HDF, but mechanisms are poorly understood.

Hypothesis: HDF improves the cardiovascular risk profile, growth and quality of life (QoL) compared to conventional HD. Primary outcome measures are carotid intima-media thickness (cIMT) and height standard deviation score (SDS).

Plan of investigation: Incident and prevalent patients on HDF or HD who are expected to remain on dialysis for >6-months and who have a single pool Kt/v>1.2 will be compared in a 1:1 study design. Anthropometric measures (height SDS, body mass index SDS) and QoL questionnaires will be monitored at baseline and 6-monthly. Cardiovascular measures (cIMT, pulse wave velocity, left ventricular mass index and 24-hour BP) will be measured annually. 6-monthly blood tests will measure nutritional biomarkers, mineral dysregulation, inflammation and middle-molecule clearance. Outcome measures will be standardised to the convective clearance dose per m2 body surface area. Recruitment will continue for 2½ years with minimum follow-up of 6-months.

Children will be recruited from all UK dialysis units, but small patient numbers (10-12/year) necessitate collaborations with European centres. HDF and HD patients across Europe who are part of the Cardiovascular Comorbidity in Childhood CKD (4C) study will be included and vascular scans will be captured from this study. From ESPN/ERA-EDTA registry data we estimate ~100 children on HDF over the study period.

Outcomes: If the 3H (HDF-Hearts-Height) study shows that HDF reduces cardiovascular morbidity and improves growth it may lead to HDF being adopted as the standard for in-centre dialysis.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 2019
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 21 Years
Eligibility Inclusion Criteria:

1. All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)

2. Age-matched HD patients

3. Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Rukshana Shroff London

Sponsors (1)

Lead Sponsor Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS) 12 months
Primary Change in height SDS 12 months
Secondary For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status 6 months
Secondary 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
Secondary Quality of life (QoL) questionnaires 12 months
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