HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit (HEMOTOL)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00811109 |
|
Recruitment Status
:
Completed
First Posted
: December 18, 2008
Last Update Posted
: March 3, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | 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 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | January 2010 |
| Actual Study Completion Date : | January 2010 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
- Intra-Dialytic Hypotension [ Time Frame: 60 days ]
- Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control [ Time Frame: 60 days ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811109
| France | |
| Service de Réanimation Médicale - CHU de Caen | |
| Caen, France, 14000 | |
| Principal Investigator: | Damien du CHEYRON, MD, PhD | University Hospital, Caen |
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 |
| First Posted: | December 18, 2008 Key Record Dates |
| Last Update Posted: | March 3, 2010 |
| Last Verified: | March 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 |