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| autoid | 85 |
| crg_id | CRG110500023 |
| titleoftrial | Blood volume control and temperature control study |
| acronymnoftrial | VOTE |
| website | http:// |
| identificationno | HD-VOTE-01-EU |
| leadprefix | Dr |
| leadsurname | Hoffmann |
| leadgivennames | Jorg |
| leadposition | Senior Vice President Medicine |
| leaddepartment | Medical Affaires and Medical Information |
| leadorganisation | Fresenius Medical Care Deutschland GmbH |
| leadaddress | Else-Kroner-Strasse 1, 61352 Bad Homburg, Germany |
| leademail | joer.hoffmann@fmc-ag.com |
| leadphone | +4961726092221 |
| leadfax | +4961726092314 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Wojke |
| contactgivennames | Ralf |
| contactposition | Clinical Research Manager |
| contactdepartment | Clinical Resarch |
| contactorganisation | Fresenius Medical Care Deutschland GmbH |
| contactaddress | Daimlerstrasse 15, 61352 Bad Homburg, Germany |
| contactemail | ralf.wojke@fmc-ag.com |
| contactphone | +4961726092316 |
| contactfax | +4961726092386 |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Fresenius Medical Care Deutschland GmbH |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | crossover |
| blinding_patients | yes |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | Sep 2004 |
| actualstart | Sep 2004 |
| proposedcompletiondate | Dec 2005 |
| actualcompletiondate | Feb 2006 |
| multi_center_study | yes |
| numberofcentres | 7 |
| multi_national_study | yes |
| countrycentres | Serbia and Montenegro |
| researchquestion | Standard hemodialysis versus hemodialysis with feedback control of blood volume and blood temperature in hypotension-prone patients:
Reduction of hemodialysis sessions with intradialytic morbid events? |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | chronic renal failure |
| intervention1 | blood volume feedback control |
| intervention2 | blood temperature feedback control |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | N/A |
| totalrecruitment | 25 |
| inclusion | History of cardiovascular instability during hemodialysis,
Hemodialysis for more than 3 months, Age at least 18 years, Stable blood pressure medication, Heamodialysis treatment time at least 3 hours |
| exclusion | Severe anemia,
Planned hospitalisation, Vascular access problems, Life expextancy below 15 weeks, Ascites liver disease, Heart failure (NYHA4), Anihypotensive medication, Obligatory single needle treatment, Inability to understand or to sign informed consent, Planned change of dialysate composition, Planned change of erythropoietin dosage, Varying dialysate sodium concentration, Pregnancy orlactation, Drug abuse, Participation in another trial within 30 days |
| primaryoutcomes | Intradialytic cardiovascular instability |
| secondaryoutcomes | Blood pressure
Thermal energy balance, Relative blood volume decrease |
| reference |