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Study identifier: NCT05754372 Synced from ClinicalTrials.gov · July 28, 2026
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Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

Condition: Hyperammonemic Encephalopathy  ·  Sponsor: University Hospital, Ghent

PhaseN/A
Planned participants10
Who can joinAll sexes, N/A to 1 Year
Healthy volunteersNo

About this study

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.

Talk to the study team

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

Always discuss trial participation with your own doctor first.

Locations (1)

Ghent University Hospital - Department of Paediatric NephrologyGhent, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT05754372