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

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 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:

MedlinePlus related topics: Dialysis

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

Intra-Dialytic Hypotension [ Time Frame: 60 days ]

Secondary Outcome Measures:

Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control [ Time Frame: 60 days ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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

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.


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

Keywords provided by University Hospital, Caen:


Acute Kidney Injury Critical care Hypotension Renal replacement therapy	Efficacy Tolerance Outcome

Additional relevant MeSH terms:


Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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