NCT04896281 Phenylalanine-free Diet for Patients With Secondary Hyperphenylalaninemia in ICU
| NCT ID | NCT04896281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Non-Phenylketonuric Hyperphenylalaninemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-07-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-07-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
CHAO-HUNG WANG, MD, PhD
PRINCIPAL INVESTIGATOR
Chang Gung Memorial Hospital, Keelung
Frequently Asked Questions
Who can join the NCT04896281 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Non-Phenylketonuric Hyperphenylalaninemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04896281 currently recruiting?
Yes, NCT04896281 is actively recruiting participants. Contact the research team at bearty@cgmh.org.tw for enrollment information.
Where is the NCT04896281 trial being conducted?
This trial is being conducted at Keelung, Taiwan.
Who is sponsoring the NCT04896281 clinical trial?
NCT04896281 is sponsored by Chang Gung Memorial Hospital. The principal investigator is CHAO-HUNG WANG, MD, PhD at Chang Gung Memorial Hospital, Keelung. The trial plans to enroll 100 participants.