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

Caen University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemodialysis

Treatments: Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring; Device: with Blood Volume Management (BVM®) only; Device: Standard Hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT00811109

A08-D12-VOL.6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Standard

No Intervention group

Description:

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

Treatment:

Device: Standard Hemodialysis

2

Active Comparator group

Description:

With Blood Volume on-line monitoring only

Treatment:

Device: with Blood Volume Management (BVM®) only

3

Active Comparator group

Description:

With Blood volume and Blood temperature on-line monitoring

Treatment:

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