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van CCT (UK)

van CCT (UK)

Circulatie veranderingen in niertransplantaties bij kinderen met levende donor

- candidate number28343
- NTR NumberNTR6900
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-dec-2017
- Secondary IDsNL 61392.091.17 METC
- Public TitleCirculatie veranderingen in niertransplantaties bij kinderen met levende donor
- Scientific TitleCirculation and Hemodynamics in Living Donation of Kidney Transplantation in Children
- hypothesisAdequate perfusion of an adult-sized renal graft in children demands significant hemodynamic changes after transplantation (Tx). Suboptimal renal graft perfusion due to inadequate hemodynamic adaptation increases the risk of loss of renal graft mass and function. This risk is especially large in the smaller and younger recipients. Current monitoring of renal graft perfusion in the post transplantation period is insufficient to detect early deterioration in blood supply. Goal of this study is to develop a non-invasive, bed-side monitor for renal perfusion after pediatric kidney transplantation. Moreover, pharmacokinetic changes after adult sized kidney transplantation in young children are largely unknown As signiflcant changes are expected, caused by increased renal and possibly hepatic blood flow, this study will investigate the pharmacokinetic (Pk) model of several pharmacons in this specific patient group.
- Healt Condition(s) or Problem(s) studiedRenal disease, Renal transplant , Live kidney donors
- Inclusion criteriaRecipients:
1)Age between 0-15 years.
2) Scheduled for living donor kidney transplantation.
3) Signed informed consent by recipient and/or parents.
4) Bodyweight maximum 40 kg

1)Accepted as kidney donor for the pediatric recipient by the responsible doctors.
2) Signed informed consent

1) Biological parent of the donor kidney recipient
2) Signed informed consent
- Exclusion criteriaExclusion criteria for participation of the recipients are complex congenital cardiac diseases (hemodynamic significant intracardiac shunts, cyanotic cardiac disease) and refusal of consent. Subjects with a contra-indication for MRI can be enrolled in the study to participate in all other investigations (biomarker en Pk profile, cardiac output analysis).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 9-nov-2017
- planned closingdate9-nov-2022
- Target number of participants20
- Interventionscardiac ultrasound
ultrasound donor kidney
blood and urine sampling
cardiac output monitoring
- Primary outcomeabsolute values and changes of CO and flow in aorta, a. renalis donor kidney
qualitative perfusion of donorkidney
biomarker concentration in blood and urine
pharmacon and metabolite concentration in blood
- Secondary outcome-patient characteristics recipient: sex, age, weight, length, renal disease, co-morbidities, medical history, medication
-laboratory results, e.g. renal function
-hemodynamic parameters (blood pressure, heart rate) during the study period
-fluid administration
-medication (inotropes and antihypertensive drugs)
-surgical and anesthetic record of the kidney transplantation
-number of hospital admissions first year postKT plus cause of admission
-ICU and hospital stay after KT
-renal graft ischaemic times (cold and warm)
-patient and graft survival
-postoperative complications KT
- Timepointsacceptor:
pre-transplantation: MRI and ultrasound (US) kidney/aorta, cardiac US, CO measurement , blood and urine sampling.
post transplantation: MRI and US kidney, cardiac US, CO measurement, blood and urine sampling.
1,3, 12 months post transplantation:
US kidney, blood and urine sampling
6 mo postTx echo cor, MRI and US kidney, blood and urine sampling
donor: MRI and US kidney. DNA analysis
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summarysingle center, pilot study in children with kidney transplantation of living donor (LDKT) to investigate hemodynamic and circulation changes, kidney specific biomarker profiles and pharmacokinetic differences after KT.
- Main changes (audit trail)
- RECORD12-dec-2017 - 4-jan-2018

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