NCT00811109

HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit

HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
DEVICE	Standard Hemodialysis	Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)
DEVICE	with Blood Volume Management (BVM®) only	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)
DEVICE	with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring	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)

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-12-18
• Last updated: 2010-03-03

Locations

1 site across 1 country: France