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

Study Overview
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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.

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.

Official Title
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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.

Conditions
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Hemodialysis

Intervention / Treatment
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* Device: Standard Hemodialysis
* Device: with Blood Volume Management (BVM®) only
* Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Acute Kidney injury requiring intermittent hemodialysis Exclusion Criteria: Age < 18 years End-stage renal failure Inclusion in other protocol Absence of consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity | Device: Standard Hemodialysis<br>* Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)<br>* Other names: Treatment A;|
| Active Comparator: 2<br>With Blood Volume on-line monitoring only | Device: with Blood Volume Management (BVM®) only<br>* 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)<br>* Other names: Treatment B;|
| Active Comparator: 3<br>With Blood volume and Blood temperature on-line monitoring | Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring<br>* 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)<br>* Other names: Treatment C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-Dialytic Hypotension |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Critical care, Hypotension, Renal replacement therapy, Efficacy, Tolerance, Outcome