Ghent University Hospital - Department of Paediatric Nephrology
Ghent, 9000, Belgium
Location status: Recruiting
Location contact
Evelien Snauwaert, MD PhD
CONTACT
Sunny Eloot, PhD
CONTACT
NCT Number: NCT05754372
Acute neonatal hyperammonemia is associated with poor neurological outcomes and high mortality. A user-friendly and widely applicable algorithm - based on kinetics - to tailor the treatment of acute neonatal hyperammonemia. A single compartmental model was calibrated assuming a distribution volume equal to the patient's total body water (V), as calculated using Wells' formula, and dialyzer clearance as derived from the measured ammonia time-concentration curves during 11 dialysis sessions in four patients (3.2 +/- 0.4 kg). Based on these kinetic simulations, dialysis protocols could be derived for clinical use with different body weights, start concentrations, dialysis machines/dialyzers and dialysis settings (e.g., blood flow QB). By a single measurement of ammonia concentration at the dialyzer inlet and outlet, dialyzer clearance (K) can be calculated as K = QB[(Cinlet - Coutlet)/Cinlet]. The time (T) needed to decrease the ammonia concentration from a predialysis start concentration Cstart to a desired target concentration Ctarget is then equal to T = (-V/K)LN(Ctarget/Cstart). By implementing these formulae in a simple spreadsheet, medical staff can draw an institution-specific flowchart for patient-tailored treatment of hyperammonemia.
The aim of this study is to validate these formula with a prospective study.
Interested in participating?
Request InfoUp to 1 year
All sexes
Observational
Ghent, 9000, Belgium
Location status: Recruiting
Evelien Snauwaert, MD PhD
CONTACT
Sunny Eloot, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia, based on kinetic modelling
Time frame: 1 year
serum ammonium levels
Time frame: 1 year
serum and dialysate concentration (mg/dL) of sodium benzoate and L-arginine
Contact information is provided by the study sponsor or research team.
Evelien Snauwaert, MD, PhD
CONTACT
Sunny Eloot, PhD
CONTACT
University Hospital, Ghent
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.