Clinical trial NCT00811109: HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hemodialysis
Keywords: Acute Kidney Injury
Critical care
Hypotension
Renal replacement therapy
Efficacy
Tolerance
Outcome
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra-Dialytic Hypotension
timeFrame: 60 days
Secondary outcomes:
measure: Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control
timeFrame: 60 days
Other outcomes:
Locations:
city: Caen
country: France
facility: Service de Réanimation Médicale - CHU de Caen
Study officials:
affiliation: University Hospital, Caen
name: Damien du CHEYRON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: du Cheyron D, Terzi N, Seguin A, Valette X, Prevost F, Ramakers M, Daubin C, Charbonneau P, Parienti JJ. Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial. Nephrol Dial Transplant. 2013 Feb;28(2):430-7. doi: 10.1093/ndt/gfs124. Epub 2012 Apr 25.