Phenylalanine-free Diet for Patients With Secondary Hyperphenylalaninemia in ICU

Recruiting now · Not applicable

Conditions studied: Non-Phenylketonuric Hyperphenylalaninemia

In brief

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.

Key facts

Study ID

NCT04896281

Run by

Chang Gung Memorial Hospital

People needed

100

Starts

2021-07-30

Expected to finish

2026-12-31

Last updated by the study team

2026-03-20

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• had Acute Physiology And Chronic Health Evaluation (APACHE II) scores of ≥15;
• were expected to stay in the ICU >48 hours;
• patients with baseline PHE levels of ≥95 uM;
• were over 20 years old.

You may not qualify if…

• patients with comorbid disorders other than the main cause for admission that might compromise their survival within three months, such as terminal stage cancer;
• patients with expected survival <3 days.

Where it is running

• Chang Gung Memorial Hospital — Keelung, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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