Condition: Hyperammonemic Encephalopathy · Sponsor: University Hospital, Ghent
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.
This description comes directly from the study's public registry record.
Evelien Snauwaert, MD, PhD · 00 32 9 332 69 05 · evelien.snauwaert@uzgent.be
Sunny Eloot, PhD · 00 32 9 332 10 25 · sunny.eloot@ugent.be
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| Ghent University Hospital - Department of Paediatric Nephrology | Ghent, Belgium | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05754372