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

Phase 2

Completed

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

• Registration Number: NCT00811109
• Lead Sponsor: University Hospital, Caen

Brief 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard Hemodialysis	Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity
2	with Blood Volume Management (BVM®) only	With Blood Volume on-line monitoring only
3	with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring	With Blood volume and Blood temperature on-line monitoring

Primary Outcome Measures

Name	Time	Method
Intra-Dialytic Hypotension	60 days

Secondary Outcome Measures

Name	Time	Method
Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control	60 days

Trial Locations

Locations (1)

Service de Réanimation Médicale - CHU de Caen; 🇫🇷 Caen, France