Effect of Amino Acid Dialysis Solution on Nutritional Status
Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study
This study tests if using an amino acid dialysis solution can help improve the nutrition of people on peritoneal dialysis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The People's Hospital of Gaozhou Academic / other |
| Locations | 1 site (Gaozhou, Guangdong) |
| Trial ID | NCT06358820 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of an amino acid peritoneal dialysis solution in improving the nutritional status of patients undergoing maintenance peritoneal dialysis. It employs a multicenter, open-label, prospective design where each participant acts as their own control, receiving one bag of amino acid solution daily alongside glucose solutions for six months. Nutritional assessments and safety indicators are measured before treatment and at three and six months into the treatment. Adverse events are also monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are uremic patients aged 18 to 75 with malnutrition who have been on maintenance peritoneal dialysis for at least three months.
Not a fit: Patients with allergies to amino acids, recent peritonitis, or other high catabolic metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the nutritional status of patients on peritoneal dialysis, potentially improving their overall health outcomes.
How similar studies have performed: While similar approaches have been explored, this specific use of amino acid peritoneal dialysis solution is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level\<3.5g/dL (35g/L), (2) prealbumin\<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of\>7; 2. Blood urea nitrogen ≤ 38mmol/L; 3. The patient's age is between 18 and 75 years old; 4. The patient signs an informed consent form. Exclusion Criteria: 1. Individuals who are allergic to any amino acids or excipients in this product 2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month; 3. Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids; 4. Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases; 6. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.
Where this trial is running
Gaozhou, Guangdong
- Gaozhou People's Hospital — Gaozhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Deng Shanshan
- Email: 276531255@qq.com
- Phone: 8613927596600
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.