RECRUITINGINTERVENTIONAL

Phenylalanine-free Diet for Patients With Secondary Hyperphenylalaninemia in ICU

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. had Acute Physiology And Chronic Health Evaluation (APACHE II) scores of ≥15; 2. were expected to stay in the ICU \>48 hours; 3. patients with baseline PHE levels of ≥95 uM; 4. were over 20 years old. Who Should NOT Join This Trial: 1. patients with comorbid disorders other than the main cause for admission that might compromise their survival within three months, such as terminal stage cancer; 2. patients with expected survival \<3 days. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. had Acute Physiology And Chronic Health Evaluation (APACHE II) scores of ≥15; 2. were expected to stay in the ICU \>48 hours; 3. patients with baseline PHE levels of ≥95 uM; 4. were over 20 years old. Exclusion Criteria: 1. patients with comorbid disorders other than the main cause for admission that might compromise their survival within three months, such as terminal stage cancer; 2. patients with expected survival \<3 days.

Treatments Being Tested

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