Actively Recruiting

Age: 0 - 1Year
All Genders
NCT05754372

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

Age: 0 - 1Year
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe acute neonatal hyperammonaemia requiring acute hemodialysis
  • Diagnosis of inborn error of metabolism
  • Younger than 1 year of age
Not Eligible

You will not qualify if you...

  • Older than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital - Department of Paediatric Nephrology

Ghent, Belgium, 9000

Actively Recruiting

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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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