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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity

Group Type NO_INTERVENTION

Standard Hemodialysis

Intervention Type DEVICE

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)

2

With Blood Volume on-line monitoring only

Group Type ACTIVE_COMPARATOR

with Blood Volume Management (BVM®) only

Intervention Type DEVICE

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)

3

With Blood volume and Blood temperature on-line monitoring

Group Type ACTIVE_COMPARATOR

with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring

Intervention Type DEVICE

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)

Interventions

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Standard Hemodialysis

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)

Intervention Type 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)

Intervention Type 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)

Intervention Type DEVICE