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

2014-08-27 03:25:35 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hemodialysis

Intervention

Standard Hemodialysis, with Blood Volume Management (BVM®) only, with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring

Location

Service de Réanimation Médicale - CHU de Caen
Caen
France
14000

Status

Completed

Source

University Hospital, Caen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:35-0400

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The volume of the HEART, usually relating to the volume of BLOOD contained within it at various periods of the cardiac cycle. The amount of blood ejected from a ventricle at each beat is STROKE VOLUME.

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Method for determining the circulating blood volume by introducing a known quantity of foreign substance into the blood and determining its concentration some minutes later when thorough mixing has occurred. From these two values the blood volume can be calculated by dividing the quantity of injected material by its concentration in the blood at the time of uniform mixing. Generally expressed as cubic centimeters or liters per kilogram of body weight.

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Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


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