NCT05754372

Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hyperammonemic Encephalopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia	user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia, based on kinetic modelling

Timeline

• Start date: 2023-01-15
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-03-03
• Last updated: 2024-04-15

Locations

1 site across 1 country: Belgium