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RECRUITING
NCT04896281
NA

Phenylalanine-free Diet for Patients With Secondary Hyperphenylalaninemia in ICU

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

Hyperphenylalaninemia is not only present in patients with congenital phenylketonuria. In adults with critical illness, hyperphenylalaninemia is noted in some patients and is associated with high mortality rate. Hyperphenylalaninemia can cause metabolic acidosis, brain dysfunction, and metabolic disturbance. The investigators would like to see whether the phenylalanine-free milk for congenital phenylketonuria is also effective in lowering the blood phenylalanine concentrations in patients with critical illness in intensive care unit and hyperphenylalaninemia.

Official title: Phenylalanine-free Diet Lowers the Blood Phenylalanine Levels in Patients With High Phenylalanine Level in the Intensive Care Unit

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-07-30

Completion Date

2026-12-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Phenylalanine-free milk

Once a plasma PHE level of ≥ 95 μM is noted, phenylalanine-free diet (Phenex-2®, Abbott Nutrition, Ohio, USA; or Phenyl-Free 2®, Mead Johnson Nutrition, Minnesota, USA) is started as the only nutrition source for enteral feeding, as per the recommendation of dieticians, in the following 4 days. The phenylalanine-free diet is free of PHE but is enriched with protein, potassium, tyrosine, and antioxidant micronutrients. After the completion of the study, diet will be back to normal diet for all patients.

Locations (1)

Chang Gung Memorial Hospital

Keelung, Taiwan