Haemodialyzed PatientsBIAHDNCT01828658
Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients
A study testing Strict bioimpedance guided dry weight prescription in people with Haemodialyzed Patients and Volume Status, run by Grigore T. Popa University of Medicine and Pharmacy.
Trial summary
The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialyzed Patients, Volume Status
- What is being tested?
- Strict bioimpedance guided dry weight prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2011
- Phase
- Interventional
- 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
- older than 18-year
- on chronic hemodialysis for more than 3 months
Who cannot join
- life expectancy of less than 1 year
- Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):
- severe ascites (decompensated liver failure)
- limb amputations
- cardiac stent, pacemaker or defibrillator
- hip prosthetic
- pregnancy
- mental deficiency (impossibility to give consent)
About this study
Official title: Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.
Read the detailed description
The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.
The duration of the study was 3,5 years.
During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.
In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).
In the control arm dry weight assessment was done by traditional clinical methods.
In both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.
In the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.
The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.
Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.
Secondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.
During the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.
- Conditions
- Haemodialyzed Patients, Volume Status
- Being tested
- Strict bioimpedance guided dry weight prescription
- Keywords
- hemodialysis, fluid management, bioimpedance, mortality, arterial stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict bioimpedance guided dry weight prescriptionOther
Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).
| Study group | Role | What they receive |
|---|---|---|
| Clinical (control) | No intervention | In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment. |
| Bioimpedance arm | Active comparator | Strict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months. Receives: Other: Strict bioimpedance guided dry weight prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
We assessed all-cause mortality in the two arms of the study at the end of intervention period.
Measured: 2,5 years follow-up
Secondary outcomes (3)
Arterial stiffness
Arterial stiffness was evaluated by applanation tonometry, measuring pulse wave velocity, and was done with a SphygmoCor® device (AtCor Medical, Westmead, Sydney, Australia).
Measurements were performed in both arms at baseline, end of intervention (2,5 years) and at the end of the study (3,5 years).
Measured: 3,5 years
Blood pressure values
In both arms, blood pressure was measured predialysis every 3 months and noted as a mean of the previous 3 predialysis BP values.
Measured: 2,5 years
Overhydration
Overhydration was evaluated in both arms of the study using the Body Composition Monitor (BCM device), every 3 months. Overhydration was quantified as Relative fluid overload (RFO = overhydration/ total body water - as measured by the BCM.
Measured: 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodialyzed PatientsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Adrian Covic, Professor, Principal investigator, University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828658
- Sponsor's protocol ID
- BCM0913
- Acronym
- BIAHD
- Status last verified
- Oct 2013
- First submitted
- 7 Apr 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.
PubMed 24583055
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01828658
- Acronym / sponsor ID
- BIAHD / BCM0913
- Conditions
- Haemodialyzed Patients, Volume Status
- Keywords
- hemodialysis, fluid management, bioimpedance, mortality, arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Apr 2013 (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 investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.
Detailed description
The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.
The duration of the study was 3,5 years.
During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.
In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).
In the control arm dry weight assessment was done by traditional clinical methods.
In both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.
In the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.
The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.
Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.
Secondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.
During the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical (control) | No intervention | –In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment. |
| Bioimpedance arm | Active comparator | Other: Strict bioimpedance guided dry weight prescriptionStrict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18-year
- on chronic hemodialysis for more than 3 months
Key exclusion criteria (8 listed)
- life expectancy of less than 1 year
- Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):
- severe ascites (decompensated liver failure)
- limb amputations
- cardiac stent, pacemaker or defibrillator
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 |
|---|---|---|
| Strict bioimpedance guided dry weight prescriptionPost dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg). | Other | Bioimpedance arm |
Primary outcome
All cause mortality
Time frame: 2,5 years follow-up
We assessed all-cause mortality in the two arms of the study at the end of intervention period.
3 secondary outcomes
Arterial stiffness
Time frame: 3,5 years
Blood pressure values
Time frame: 2,5 years
Overhydration
Time frame: 2,5 years
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 16 Oct 2013.
- Derived from this study: PubMed 24583055Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.
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.
Adrian Covic, Professor principal investigator
University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department
Questions about this trial
What is this clinical trial studying?
A study testing Strict bioimpedance guided dry weight prescription in people with Haemodialyzed Patients and Volume Status, run by Grigore T. Popa University of Medicine and Pharmacy.
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 2 inclusion and 8 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
All cause mortality (time frame: 2,5 years follow-up). 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 NCT01828658, which also lists 1 linked publication.
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 16 Oct 2013.