Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05755503
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-03-02
Brief Title:
Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients
Sponsor:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Organization:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Study Overview
Official Title:
Toxicokinetics of Protein-bound Uremic Toxins in ESRD Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 models fit and predictive value were validated in a group of MHD patients treated with HP without residual kidney
Detailed Description:
The results of this study are helpful to clarify the rules of clearance and metabolism of PBUTs in hemodialysis patients and lay a foundation for exploring effective means of blood purification and drugs to eliminate PBUTs so as to reduce the incidence and mortality of complications in uremia patients
Hemodialysis parameter setting Blood flow 250mlmin high throughput dialysis mode dialysis process lasted for 4h
Samples collection time pointBlood samples before hemodialysis 1h 2h 4h after hemodialysis 05h 1h 2h 4h 8h 12h 24h 48h after hemodialysisDialysate samples 1h 15h 2h 3h 4h after hemodialysisUrine samples 4h urine samples during hemodialysisHemoperfusion samples before hemodialysis 5min 15min 30min 45min 60min 90min 120min after hemodialysis
The proposed model of IS toxicokinetics is a three-compartment model in which the circulatory system is the central compartment intertissue fluid is the fast equilibrium chamber and cerebrospinal fluid intracellular fluid lymphatic fluid etc are the slow equilibrium chamber
Hemodialysis parameter setting Blood flow 250mlmin high throughput dialysis mode dialysis process lasted for 4h
Samples collection time pointBlood samples before hemodialysis 1h 2h 4h after hemodialysis 05h 1h 2h 4h 8h 12h 24h 48h after hemodialysisDialysate samples 1h 15h 2h 3h 4h after hemodialysisUrine samples 4h urine samples during hemodialysisHemoperfusion samples before hemodialysis 5min 15min 30min 45min 60min 90min 120min after hemodialysis
The proposed model of IS toxicokinetics is a three-compartment model in which the circulatory system is the central compartment intertissue fluid is the fast equilibrium chamber and cerebrospinal fluid intracellular fluid lymphatic fluid etc are the slow equilibrium chamber
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None