A Phase 2/3 interventional study of Standard Hemodialysis and with Blood Volume Management (BVM®) only in Hemodialysis, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-03.
Sponsored by University Hospital, Caen · Phase 2/3, Interventional, and Treatment
The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.
Acute kidney injury (AKI) is associated with high mortality and morbidity rates in critically ill patients despite advances in renal replacement therapy (RRT). Over the last few years, new devices in dialysis equipment, such as blood temperature and blood volume on-line monitors, have been developed to improve hemodynamic tolerance, and these new modalities have demonstrated their positive impact on decrease in intra-dialytic hypotension rate in chronic hemodialysis patients. In order to evaluate these new devices in critically ill patients with acute kidney injury we decided to conduct a prospective randomized controlled trial.
We based calculation of the sample size on a power analysis that assumed an expected decrease in intra-dialytic hypotension rate of 40% (from a crude intra-dialytic hypotension rate of 30% to 18%) in groups B and C, compared with group A. Analysis is done by intention to treat, according to prescribed new dialysis on-line monitoring devices.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity
Device: Standard Hemodialysis
With Blood Volume on-line monitoring only
Device: with Blood Volume Management (BVM®) only
With Blood volume and Blood temperature on-line monitoring
Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring
Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)
Also known as: Treatment A
Hemodialysis using Blood Volume on-line monitoring only. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® device (for blood volume monitor; Fresenius Medical Care, France)
Also known as: Treatment B
Hemodialysis using Blood volume and Blood temperature on-line monitoring. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® and BTM® devices (for blood volume monitor and blood temperature management, respectively; Fresenius Medical Care, France)
Also known as: Treatment C
Intra-Dialytic Hypotension
Time frame: 60 days
Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control
Time frame: 60 days
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen