Phenylalanine-free diet for ICU patients with high phenylalanine levels
Phenylalanine-free Diet Lowers the Blood Phenylalanine Levels in Patients With High Phenylalanine Level in the Intensive Care Unit
This study tests if a special milk diet without phenylalanine can help ICU patients with high phenylalanine levels feel better and improve their health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Keelung) |
| Trial ID | NCT04896281 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a phenylalanine-free milk diet on patients in the intensive care unit (ICU) who have elevated blood phenylalanine levels. The research aims to determine if this dietary intervention can lower blood phenylalanine concentrations and improve patient outcomes. Given the association between high phenylalanine levels and increased mortality, the study seeks to provide a potential treatment strategy for adults suffering from secondary hyperphenylalaninemia. The intervention will be administered to eligible patients who are expected to remain in the ICU for more than 48 hours.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old with high blood phenylalanine levels and an APACHE II score of 15 or higher, expected to stay in the ICU for more than 48 hours.
Not a fit: Patients with terminal illnesses or those expected to survive less than three days are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce mortality rates and improve recovery outcomes for critically ill patients with elevated phenylalanine levels.
How similar studies have performed: While there is established treatment for infants with congenital phenylketonuria, this approach for adults in critical care is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Keelung
- Chang Gung Memorial Hospital — Keelung, Taiwan (Recruiting)
Study contacts
- Principal investigator: CHAO-HUNG WANG, MD, PhD — Chang Gung Memorial Hospital, Keelung
- Study coordinator: CHAO-HUNG WANG, MD, PhD
- Email: bearty@cgmh.org.tw
- Phone: 0224313131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.