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Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia

G

Ghent University Hospital (UZ)

Status

Enrolling

Conditions

Hyperammonemic Encephalopathy

Treatments

Diagnostic Test: user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia

Study type

Observational

Funder types

Other

Identifiers

NCT05754372
BC-10637

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • severe acute neonatal hyperammonaemia for which acute hemodialysis is indicated
  • inborn error of metabolism
  • below 1 year of age

Exclusion criteria

  • older than 1 year

Trial design

10 participants in 1 patient group

Hyperammonaemia
Treatment:
Diagnostic Test: user-friendly and widely applicable algorithm to tailor the treatment of acute neonatal hyperammonemia

Trial contacts and locations

1

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Central trial contact

Sunny Eloot, PhD; Evelien Snauwaert, MD, PhD

Data sourced from clinicaltrials.gov

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