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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemodialysis
 Device: Standard Hemodialysis
Device: with Blood Volume Management (BVM®) only
Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Intra-Dialytic Hypotension [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 600
Study Start Date: December 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard
Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity
 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
Active Comparator: 2
With Blood Volume on-line monitoring only
 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
Active Comparator: 3
With Blood volume and Blood temperature on-line monitoring
 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

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811109

Locations
France
Service de Réanimation Médicale - CHU de Caen
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Principal Investigator: Damien du CHEYRON, MD, PhD University Hospital, Caen
  More Information

No publications provided by University Hospital, Caen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TERZI/MD, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT00811109     History of Changes
Other Study ID Numbers: A08-D12-VOL.6
Study First Received: December 15, 2008
Last Updated: March 2, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Caen:
Acute Kidney Injury
Critical care
Hypotension
Renal replacement therapy
 Efficacy
Tolerance
Outcome

ClinicalTrials.gov processed this record on March 03, 2015