Haemodiafiltration vs Conventional Haemodialysis in Children (3H)

February 21, 2018 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust

The Effects of Haemodiafiltration (HDF) vs Conventional Haemodialysis (HD) on Growth and Cardiovascular Markers in Children - 3H (HDF, Hearts and Height) Study

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children on HDF
Children on conventional HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS)
Time Frame: 12 months
12 months
Change in height SDS
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status
Time Frame: 6 months
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
Time Frame: 12 months
12 months
Quality of life (QoL) questionnaires
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Investigators

  • Study Chair: Rukshana C Shroff, MD FRCPCH PhD, Great Ormond Street Hospital For Children NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13NU02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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