Haemodiafiltration vs Conventional Haemodialysis in Children (3H)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02063776|
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Last Update Posted : February 22, 2018
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.
|Condition or disease|
|Children Haemodialysis Haemodiafiltration|
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|
|Actual Enrollment :||150 participants|
|Official Title:||The Effects of Haemodiafiltration (HDF) vs Conventional Haemodialysis (HD) on Growth and Cardiovascular Markers in Children - 3H (HDF, Hearts and Height) Study|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||December 2019|
|Children on HDF|
|Children on conventional HD|
- 1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS) [ Time Frame: 12 months ]
- Change in height SDS [ Time Frame: 12 months ]
- For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status [ Time Frame: 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 ]
- Quality of life (QoL) questionnaires [ Time Frame: 12 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063776
|London, United Kingdom, WC1N 3JH|
|Study Chair:||Rukshana C Shroff, MD FRCPCH PhD||Great Ormond Street Hospital for Children NHS Foundation Trust|