Primary objective is to design a non-invasive, bedside monitoring strategy for early detection of renal graft hypoperfusion after pediatric kidney transplantation, using transabdominal ultrasonography and biomarker surveillance in serum and urine.…
ID
Source
Brief title
Condition
- Renal and urinary tract disorders congenital
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1)Absolute values and percentage change in CO, AoBF and transplanted renal
artery blood flow (TxRBF) after adult-sized kidney transplantation in pediatric
recipients.
2) urine and serum biomarker concentrations.
3) pharmacon and metabolite serum concentrations.
(see page 15 research protocol)
Secondary outcome
see page 16 research protocol
Background summary
Adequate 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 significant 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.
Study objective
Primary objective is to design a non-invasive, bedside monitoring strategy for
early detection of renal graft hypoperfusion after pediatric kidney
transplantation, using transabdominal ultrasonography and biomarker
surveillance in serum and urine.
Secondary objective is to define a pharmacokinetic (Pk) model for adult sized
kidney transplantation in children.
Study design
This is a prospective clinical pilot study.
Study burden and risks
The extra burden for the participants consists of blood sampling, additional
MRI and ultrasound investigations in addition to standard of care in pediatric
kidney transplantation. In small children this implies an extra anesthesia
session for the performance of the last MRI. Extra blood samples will be drawn
as part of regular blood sampling in standard of care and will not exceed the
maximum allowable amounts.
Benefits are especially accounted for the future pediatric kidney transplant
patients. Though, imaging the renal graft during follow up can also benefit the
study subjects as it is able to detect early deterioration in renal graft blood
supply and perfusion. This study can only be done in this patient group as
hemodynamic changes are age and body-weight specific and especially the
smallest recipients are at risk for inadequate renal graft perfusion because of
large allograft-recipient size mismatch. Adult data about hemodynamic
responses, renal graft perfusion and pharmacokinetic changes cannot be
extrapolated to the pediatric population.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
recipients (children; 20 persons):
1) Age between 0-17 years, bodyweight < 40 kg
2) Scheduled for living donor kidney transplantation.
3) Signed informed consent by child and/or parents. ;Donors (adults;20 persons):
1)Accepted as kidney donor for the pediatric recipient by the treating doctors.
2) Signed informed consent;Parents (2 per recipient/child)
1) signed informed consent
Exclusion criteria
complex congenital heart disease in the acceptor (child) and refusal of informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL61392.091.17 |
OMON | NL-OMON22098 |