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| autoid | 88 |
| crg_id | CRG120500025 |
| titleoftrial | EXPANSION OF BLOOD VOLUME INCREASE PATENCY RATE OF PRIMARY ARTERIOVENOUS FISTULAS (AVF) IN PATIENTS WITH CRITICAL QUALLITY OF VESSELS |
| acronymnoftrial | Arteriovenous fistula patency and blood volume |
| website | http:// |
| identificationno | Grant number: L3-4486-0312 and P3-0323-0312 |
| leadprefix | Prof |
| leadsurname | Malovrh |
| leadgivennames | Marko |
| leadposition | Head of Center for haemodialysis |
| leaddepartment | Department of Nephrology |
| leadorganisation | University Medical Center Ljubljana |
| leadaddress | Zaloska 7, Ljubljana, 1525, Slovenia |
| leademail | marko.malovrh@kclj.si |
| leadphone | +386 1 5222941 |
| leadfax | +386 1 5222460 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
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| funding | govt |
| otherfunding | |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 09/1999 |
| actualstart | |
| proposedcompletiondate | |
| actualcompletiondate | 12/2003 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | Slovenia |
| researchquestion | The purpose of this prospective study was to find out if blood volume expansion and consequently increased flow through the feeding artery can prevent early arteriovenous fistula function in the risk group of patients. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | chronic renal failure |
| intervention1 | Hemohes 6%, Braun, Melsungen, Germany |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | both |
| age | older than 18 years |
| totalrecruitment | 120 |
| inclusion | 1. dialysis and pre-dialysis patients
2. internal diameter of feeding artery =< 1.6 mm 3. resistance index at reactive hyperemia by duplex ultrasound > 0.7 |
| exclusion | 1. internal diameter of feeding artery > 1.6 mm
2. resistance index at reactive hyperemia by duplex ultrasound < 0.7 |
| primaryoutcomes | primary patency rate of arteriovenous fistula |
| secondaryoutcomes | long-term arteriovenous fistula usefulness for haemodialysis treatment |
| reference | 1. Malovrh M. Native arteriovenous fistula. Preoperative evaluation. Am J Kidney Dis 2002; 39:1118-1125.
2. Owada A, Saito H, Mochizuki T, et al. Radial artery spasm in uremic patients undergoing construction of arterial hemodialysis fistulas: diagnosis and prophylaxis with intravenous nicardipine. Nephron 1993;64:37-41. 3. Owada A, Saito H, Nagai T, Iwamoto H, Shigai T. Prophylactic use of intravenous prostaglandin E1 for radial arterial spasm in uremic patients undergoing construction of arteriovenous hemodialysis fistulas. Int J Artif Organs 1994;17:511-4. 4. Franz A, Braunlich P, Gamsjager T, Felfernig M, Gustorff B, Kozek-Langenecker SA.The effects of hydroxyethyl starches of varying molecular weights on platelet function. Anesth Analg. 2001 Jun;92(6):1402-7. |