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…
ID
Source
Brief title
Condition
- Nephropathies
Health condition
renal failure pediatric living donor kidney transplantation cardiac output renal perfusion
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
absolute 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
-diuresis
-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
Background summary
single 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.
Study objective
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 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.
Study design
acceptor:
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
Intervention
cardiac ultrasound
MRI
ultrasound donor kidney
blood and urine sampling
cardiac output monitoring
Age
Inclusion criteria
Recipients:
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
Donors:
1)Accepted as kidney donor for the pediatric recipient by the responsible doctors.
2) Signed informed consent
Parents:
1) Biological parent of the donor kidney recipient
2) Signed informed consent
Exclusion criteria
Exclusion 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).
Design
Recruitment
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6666 |
| NTR-old | NTR6900 |
| CCMO | NL61392.091.17 |
| OMON | NL-OMON45477 |