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| autoid | 115 |
| crg_id | CRG030600046 |
| titleoftrial | Influence of hemodialysis, hemodiafiltration and peritoneal dialysis on asymmetric dimethylarginine and markers of oxidative stress |
| acronymnoftrial | |
| website | http:// |
| identificationno | |
| leadprefix | Dr |
| leadsurname | Eiselt |
| leadgivennames | Jaromir |
| leadposition | Lecturer |
| leaddepartment | Department of Internal Medicine I |
| leadorganisation | Charles University, School of Medicine |
| leadaddress | Alej Svobody 80, 304 60, Plzen, Czech Republic |
| leademail | eiselt@fnplzen.cz |
| leadphone | +420 377 103 925 |
| leadfax | +420 377 103 920 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Eiselt |
| contactgivennames | Jaromir |
| contactposition | Lecturer |
| contactdepartment | Department of Internal Medicine I |
| contactorganisation | Charles University, School of Medicine |
| contactaddress | Alej Svobody 80, 304 60, Plzen, Czech Republic |
| contactemail | eiselt@fnplzen.cz |
| contactphone | +420 377 103 925 |
| contactfax | +420 377 103 920 |
| funding | govt |
| otherfunding | |
| fundingnameofsponsors | Research Project No. MSM 0021620819, Ministry of Health, Czech Republic |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | crossover |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | yes |
| proposedstart | 4/2006 |
| actualstart | |
| proposedcompletiondate | 8/2006 |
| actualcompletiondate | |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Czech Republic |
| researchquestion | To test the hypothesis that 8 weeks of high-volume hemodiafiltration using polysulfon membrane provides better control of plasma levels of asymmetric dimethylarginine, advanced oxidation protein products, advanced glycation end-products and homocystein than low-flux hemodialysis. Second aim is to compare data of patients on maintenace hemodialysis and peritoneal dialysis. Third aim is to compare data of patients and heatlhy volunteers. |
| study_status_recruitment | not_yet_recruiting |
| study_status_recruitment_follow | |
| healthcarecondition | End stage renal disease, renal replacement therapy |
| intervention1 | High-volume hemodiafiltration versus low-flux hemodialysis |
| intervention2 | Peritoneal dialysis |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | minimum 18, maximum N/A |
| totalrecruitment | 58 |
| inclusion | Patients on maintenance hemodialysis or peritoneal dialysis for at least 3 months |
| exclusion | Unstable clinical condition, infection, malignancy |
| primaryoutcomes | Change in plasma levels of asymmetric dimethylarginine, advanced oxidation protein products, advanced glycation end-products and homocystein after a period of 8 weeks of hemodiafiltration or hemodialysis.
Differencies of the above mentioned markers among hemodialysis patients, peritoneal dialysis patients and healthy volunteers. |
| secondaryoutcomes | change of plasma levels of asymmetric dimethylarginine, advanced oxidation protein products, advanced glycation end-products and homocystein after a single hemodialysis/hemodiafiltration procedure and measurement of the amount of these substances in dialysate/diafiltrate. |
| reference |