Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients (NCT05755503) | Clinical Trial Compass
UnknownNot Applicable
Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients
China100 participantsStarted 2023-02-21
Plain-language summary
Protein-bound uremic toxins (PBUTs) are important uremic toxins, represented by indoxyl sulfate (IS), derived from the fermentation of dietary proteins by gut bacteria. The purpose of this study was to study the changes of IS in maintenance hemodialysis patients, and to construct a metabolic kinetics model of IS clearance. The model was then used to estimate the clearance rate of indoxyl sulfate by hemoperage, and to verify the application value of the model. This study intends to collect a series of serum, dialysate and urine samples from maintenance hemodialysis patients receiving high-throughput dialysis or hemodialysis filtration, so as to clarify the variation rule of IS during various blood purification treatments. Furthermore, a three-compartment model of dialysis IS metabolism kinetics was constructed according to the IS clearance of dialysis and residual kidney, and the above model was verified internally and externally. Finally, the model's fit and predictive value were validated in a group of MHD patients treated with HP without residual kidney.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients with maintenance hemodialysis were less than 85 years old and more than 18 years old, both male and female;
✓. Regular hemodialysis for more than 3 months, using arteriovenous fistula hemodialysis;
✓. Receiving high-throughput dialysis, HDF, and HP according to the conventional treatment regimen;
✓. Adequate dialysis (Kt/V\>1.2 within one month);
✓. 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;
✓. Understand and sign the informed consent
Exclusion criteria
✕. Patients with systemic or local severe infection;
✕. Patients with severe anemia: Hb\<60g/L;
✕. Patients with hypoproteinemia: Alb\<30g/L;
✕
What they're measuring
1
The blood concentration of IS
Timeframe: From the beginning of dialysis to 48 hours after dialysis
2
The dialysate concentration of IS
Timeframe: Four hours of dialysis
3
The urine concentration of IS
Timeframe: Four hours of dialysis
Trial details
NCT IDNCT05755503
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
. Patients with insufficient daily protein intake: nPCR\>1.0g/kg/d;
✕. Patients with malignant tumors;
✕. 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;
✕. Patients with severe hematopoietic system diseases, such as aplastic anemia, globin aplastic anemia, thrombocytopenic purpura, etc.;
✕. 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;