Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial
Official title:
Impact of Changes in Dialysis Sodium Concentration on Tissue Sodium Storage in Hemodialysis Patients
Salt (NaCl) intake is implicated in causing hypertension and cardiovascular disease, the commonest cause of death worldwide. The investigators recently established that Na+ is stored in tissues, bound to glycosaminoglycans (GAGs) in skin and muscle. The resulting local hypertonicity leads to immune cell-driven induction of local tissue electrolyte clearance via modulation of cutaneous lymph capillary density. To visualize these complex processes in man directly, the investigators established Na+ magnetic resonance imaging (23Na-MRI) and investigated Na+ stores in hemodialysis (HD) patients. Hemodialysis patients were sodium-"overloaded" and HD treatment lowered tissue Na+ stores in this study. The observed effects were highly variable and independent of Na+ or water removal from the body during a dialysis session. Tissue Na+ mobilization correlated with circulating vascular endothelial growth factor-C (VEGF-C). The investigators believe that excessive Na+ storage is a reversible condition and therefore susceptible for therapeutic interventions. The investigators hypothesize that lowering dialysate Na+ concentration may favorably affect accelerated tissue Na+ accumulation in hemodialysis patients. Besides, improved tissue Na+ storage, osmostress-induced as well as pro-inflammatory immune cell response should be affected by such a revised dialysis management.
To evaluate effects of moderate reduction of dialysate Na+ concentration on tissue Na+ content the investigators intend to recruit 40 hemodialysis patients, who will be offered a therapeutic change of their dialysate Na+ concentration. After detection of tissue Na+ content using 23Na-MRI technique, the applied dialysate [Na+] will be initially increased stepwise by 2 mmol/l per week from 138 to 142 mmol/l and maintained for a period of 5 weeks. After another 23Na-MRI measurement, dialysate [Na+] will then be lowered stepwise by 1-2 mmol/l per week to a minimum of 135 mmol/l, which will be also maintained for a period of 5 weeks followed by a final 23Na-MRI assessment. Hypothesis: Reduction of dialysate Na+ concentration will decrease tissue sodium storage. Additionally, the investigators will assess changes in body fluid distribution by bioimpedance spectroscopy. Furthermore, vascular compliance in response to the modulation of dialysate [Na+] and its correlation with tissue Na+ will be assessed. To investigate the immune response to tissue Na+ accumulation, the osmostress-induced as well as pro-inflammatory immune cell response of isolated monocytes will be quantified. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05700851 -
Immuno-nutrition Supplementation in Haemodialysis
|
N/A | |
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Completed |
NCT01464190 -
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
|
Phase 3 | |
Recruiting |
NCT06040281 -
Smart and Fit for Kidney Transplantation
|
N/A | |
Active, not recruiting |
NCT03535922 -
Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care
|
N/A | |
Completed |
NCT04622709 -
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
|
Phase 2 | |
Completed |
NCT04585607 -
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia
|
Phase 4 | |
Completed |
NCT03182699 -
Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
|
Phase 4 | |
Completed |
NCT03942744 -
The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.
|
N/A | |
Completed |
NCT04549597 -
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
|
Phase 4 | |
Recruiting |
NCT04659525 -
Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia
|
Phase 4 | |
Completed |
NCT04125537 -
Pathways Project: Kidney Supportive Care
|
||
Recruiting |
NCT03347773 -
Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
|
N/A | |
Recruiting |
NCT04397653 -
Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients
|
Phase 4 | |
Active, not recruiting |
NCT03938285 -
Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal
|
N/A | |
Completed |
NCT01324128 -
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
|
Phase 3 | |
Not yet recruiting |
NCT04600193 -
a Randomized Controlled Trial of the Intake of Organic and Inorganic Phosphate in Peritoneal Dialysis Patients
|
N/A | |
Not yet recruiting |
NCT06225544 -
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
|
Phase 2 | |
Recruiting |
NCT05209880 -
Advance Care Planning in the Emergency Department
|
N/A | |
Enrolling by invitation |
NCT05086185 -
Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients
|