Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how certain harmful substances, known as protein-bound uremic toxins (PBUTs), behave in patients undergoing regular kidney dialysis. Specifically, the study focuses on a toxin called indoxyl sulfate (IS), which comes from the breakdown of proteins in our diet. Researchers want to understand how IS levels change during different types of dialysis treatments and develop a model to predict how effectively dialysis can remove this toxin from the blood.

To participate in this trial, individuals must be between 18 and 85 years old and have been receiving maintenance hemodialysis for at least three months. Participants should be in generally good health, able to communicate about their condition, and maintain a steady diet. They will provide blood, urine, and dialysis fluid samples to help researchers learn more about IS clearance during treatment. It's important to note that people with certain severe health conditions or infections, or those who are pregnant, are not eligible to join the study. Overall, this research aims to improve the understanding of how dialysis works to remove harmful substances from the body, which could lead to better treatment strategies for kidney disease patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with maintenance hemodialysis were less than 85 years old and more than 18 years old, both male and female;
• • 2. Regular hemodialysis for more than 3 months, using arteriovenous fistula hemodialysis;
• • 3. Receiving high-throughput dialysis, HDF, and HP according to the conventional treatment regimen;
• • 4. Adequate dialysis (Kt/V\>1.2 within one month);
• • 5. Keep your diet steady. Generally in good condition, have self-awareness, have a good understanding of their own illness and physical condition, and can communicate well with others;
• • 6. Understand and sign the informed consent
• Exclusion Criteria:
• • 1. Patients with systemic or local severe infection;
• • 2. Patients with severe anemia: Hb\<60g/L;
• • 3. Patients with hypoproteinemia: Alb\<30g/L;
• • 4. Patients with insufficient daily protein intake: nPCR\>1.0g/kg/d;
• • 5. Patients with malignant tumors;
• • 6. Patients with severe cardiovascular and cerebrovascular diseases, such as unstable angina pectoris, malignant hypertension, persistent atrial fibrillation, abnormal Q-wave of electrocardiogram, or patients with acute myocardial infarction, stroke, or coronary stent implantation within 3 months;
• • 7. Patients with severe hematopoietic system diseases, such as aplastic anemia, globin aplastic anemia, thrombocytopenic purpura, etc.;
• • 8. Patients with severe digestive diseases, such as dysphagia, liver insufficiency, active gastrointestinal bleeding, intestinal obstruction, intestinal perforation, or previous subtotal gastrectomy, and other diseases that may affect digestion and absorption;
• • 9. Pregnant women;
• • 10. Participating in other clinical trials within one month or currently;
• • 11. Researchers consider it inappropriate.