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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00811109
First received: December 15, 2008
Last updated: March 2, 2010
Last verified: March 2010

December 15, 2008
March 2, 2010
December 2008
January 2010   (final data collection date for primary outcome measure)
Intra-Dialytic Hypotension [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00811109 on ClinicalTrials.gov Archive Site
Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Compliance to treatment; intra-dialytic complications; renal function recovery; mortality [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit
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.

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemodialysis
  • Device: Standard Hemodialysis
    Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)
    Other Name: Treatment A
  • 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)
    Other Name: Treatment B
  • 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)
    Other Name: Treatment C
  • No Intervention: Standard
    Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity
    Intervention: Device: Standard Hemodialysis
  • Active Comparator: 2
    With Blood Volume on-line monitoring only
    Intervention: Device: with Blood Volume Management (BVM®) only
  • Active Comparator: 3
    With Blood volume and Blood temperature on-line monitoring
    Intervention: Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00811109
A08-D12-VOL.6
Yes
TERZI/MD, University Hospital, Caen
University Hospital, Caen
Not Provided
Principal Investigator: Damien du CHEYRON, MD, PhD University Hospital, Caen
University Hospital, Caen
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP