HemodialysisPhase 2/3HEMOTOLNCT00811109
HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit
A Phase 2/3 study testing Standard Hemodialysis, with Blood Volume Management (BVM®) only and with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring in people with Hemodialysis, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Standard Hemodialysis, with Blood Volume Management (BVM®) only and with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Acute Kidney injury requiring intermittent hemodialysis
- Absence of consent
Who cannot join
- Age < 18 years
- End-stage renal failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Hemodialysis
- Being tested
- Standard Hemodialysis, with Blood Volume Management (BVM®) only, with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring
- Keywords
- Acute Kidney Injury, Critical care, Hypotension, Renal replacement therapy, Efficacy, Tolerance, Outcome
- Medical subject headings
- Acute Kidney Injury, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HemodialysisDevice
Also called Treatment A
Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)
with Blood Volume Management (BVM®) onlyDevice
Also called Treatment B
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)
with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoringDevice
Also called Treatment C
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)
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity Receives: Device: Standard Hemodialysis |
| 2 | Active comparator | With Blood Volume on-line monitoring only Receives: Device: with Blood Volume Management (BVM®) only |
| 3 | Active comparator | With Blood volume and Blood temperature on-line monitoring Receives: Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Dialytic Hypotension
Measured: 60 days
Secondary outcomes (1)
Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Damien du CHEYRON, MD, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811109
- Sponsor's protocol ID
- A08-D12-VOL.6
- Acronym
- HEMOTOL
- Status last verified
- Mar 2010
- First submitted
- 15 Dec 2008
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
PubMed 39498822du 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.
PubMed 22535635
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00811109
- Acronym / sponsor ID
- HEMOTOL / A08-D12-VOL.6
- Conditions
- Hemodialysis
- Keywords
- Acute Kidney Injury, Critical care, Hypotension, Renal replacement therapy, Efficacy, Tolerance, Outcome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | Device: Standard HemodialysisGold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity |
| 2 | Active comparator | Device: with Blood Volume Management (BVM®) onlyWith Blood Volume on-line monitoring only |
| 3 | Active comparator | Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoringWith Blood volume and Blood temperature on-line monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Acute Kidney injury requiring intermittent hemodialysis
- Absence of consent
Key exclusion criteria (2 listed)
- Age < 18 years
- End-stage renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard HemodialysisAlso: Treatment AGold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France) | Device | Standard |
| with Blood Volume Management (BVM®) onlyAlso: Treatment BHemodialysis 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) | Device | 2 |
| with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoringAlso: Treatment CHemodialysis 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) | Device | 3 |
Primary outcome
Intra-Dialytic Hypotension
Time frame: 60 days
1 secondary outcome
Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Derived from this study: PubMed 39498822Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.
- Derived from this study: PubMed 22535635du 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien du CHEYRON, MD, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Standard Hemodialysis, with Blood Volume Management (BVM®) only and with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring in people with Hemodialysis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-Dialytic Hypotension (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00811109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2010.