Understanding how protein-bound toxins behave in patients on hemodialysis

Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients

This study is trying to understand how certain toxins in the blood behave in patients on hemodialysis to find better ways to remove them and improve their health.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05755503 on ClinicalTrials.gov

What this trial studies

This observational study focuses on protein-bound uremic toxins, specifically indoxyl sulfate, in patients undergoing maintenance hemodialysis. It aims to construct a metabolic kinetics model to analyze the clearance of these toxins during various blood purification treatments. By collecting serum, dialysate, and urine samples at multiple time points, the study seeks to clarify the variations in indoxyl sulfate levels and validate the proposed model's predictive capabilities. The findings could lead to improved methods for eliminating these toxins and reducing complications in uremic patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have been on maintenance hemodialysis for over three months and are in stable health.

Not a fit: Patients with severe infections, anemia, hypoproteinemia, or significant cardiovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better blood purification techniques that reduce complications and mortality in patients with end-stage renal disease.

How similar studies have performed: While the approach of studying protein-bound uremic toxins is established, the specific model being tested in this study is novel and has not been extensively validated in prior research.

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.

Where this trial is running

Shanghai, Shanghai

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Ding Feng, PhD

Conditions: Uremic, Toxemia, Pharmacokinetics, Renal Dialysis