Actively Recruiting
Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Led by University Hospital, Ghent · Updated on 2024-04-15
10
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Optimalisation of the Treatment of Acute Neonatal Hyperammonaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe acute neonatal hyperammonaemia requiring acute hemodialysis
- Diagnosis of inborn error of metabolism
- Younger than 1 year of age
You will not qualify if you...
- Older than 1 year
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University Hospital - Department of Paediatric Nephrology
Ghent, Belgium, 9000
Actively Recruiting
Research Team
E
Evelien Snauwaert, MD, PhD
CONTACT
S
Sunny Eloot, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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