Fluid OverloadNCT03929471
Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
A study testing Target weight correction protocol in people with Fluid Overload and Vascular Stiffness, run by University of Alberta at 1 site in Canada.
Trial summary
Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations Applied medical device: 1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, Vascular Stiffness
- What is being tested?
- Target weight correction protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 1 Jul 2020
- 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
- Adult (>18 years old) outpatients on 3-4 times per week HD sessions for at least 6 weeks with a life expectancy >6 months.
- Fluid overload ≥1.1L.
- Medically stable patient.
- Minimum of 3 hours of dialysis per session.
Who cannot join
- Pregnancy or lactation.
- Declined informed consent.
- Patients with cognitive dysfunction.
- Severe life-limiting Comorbidities (malignant tumour, tuberculosis,....)
- Surgery within six weeks of the study.
- Nocturnal dialysis patients.
- Patients expected to receive a transplant or move to another center within the duration of the study.
- Patients with arteriovenous fistula issues.
Trial locations and contacts
1 site in 1 country.
About this study
Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations
Applied medical device:
Read more
- Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload.
- Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention.
Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension.
Aim of the study:
- To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements.
- To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use.
- To show that this approach does not lead to more episodes with intradialytic hypotension.
The number of patients: 70 patients
Read the detailed description
This study proposal is looking at the application of an accurate assessment of fluid status in hemodialysis (HD) patients to correct fluid overload. Patients undergoing hemodialysis suffer from the inability to maintain their normal body fluids and have a high probability to develop hypertension at initiation of dialysis (1). Long-standing fluid overload is no longer linked solely to high blood pressure, but also to vascular dysfunction and heart failure (1). Fluid overload is estimated based on the amount of fluids available outside the cells (extracellular fluid volume, ECFV). Thus, determination of the right amount of fluid removal during the dialysis depends on the weight of the patient when the ECFV is normal (referred to as Target Weight, TW). Essentially, TW is assessed by routine clinical judgment, for example, leg and hands swelling (edema), elevation in blood pressure and the expansion of the external jugular vein. Unfortunately, this clinical judgment is not reliable to assess fluid status (2, 3); hence, overestimation of TW occurs and leads to fluid overload. Current technology allows assessing fluid overload accurately by using bio-impedance, a non-invasive method that can be easily used in the HD setting. Despite this, very few studies have been reported where a systematic approach was followed to use bio-impedance to correct a TW that has been set too high, with the ultimate goal to correct fluid overload. Therefore, this study aims to provide better fluid control through an intervention to improve fluid status toward normovolemia by using bio-impedance assessment of fluid overload rather than clinical judgments. First, the fluid status will be measured in all study participants by multifrequency bio-impedance using a 'Body Composition Monitor' (BCM, Fresenius). Second, we will divide the study subjects into two groups; the control group which will initially receive standard conventional therapy (no intervention) for 3 months, and the intervention group will undergo by BCM measurements and integrated TW correction protocol for 3 months. Third, after three months, the control group will also involve in the same TW correction adjustment. The Primary outcome is improvement in fluid status towards normovolemia (<1.1 L fluid overload). Secondary outcomes are a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) a decrease in the use of antihypertensive medications. Altogether, an optimized fluid status via implemented fluid management plan will provide better control of fluid overload, blood pressure, and improvement in vascular function.
- Conditions
- Fluid Overload, Vascular Stiffness
- Being tested
- Target weight correction protocol
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target weight correction protocolOther
The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients to be subjected to a fluid overload correction protocol. Receives: Other: Target weight correction protocol |
| Control group | No intervention | Patient will be followed but no fluid overload correction protocol will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid volume
Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
Measured: through the study completion, an average of 6 months
Secondary outcomes (3)
Pulse wave velocity
Improvement in pulse wave velocity (millimetre/second)-one of vascular stiffness measurements
Measured: Through the study completion, an average of 6 months
Augmentation index
Improvement in augmentation index (%)-one of vascular stiffness measurements
Measured: Through the study completion, an average of 6 months
Anti hypertensive medications use
Reduction in the number of anti hypertensive medications use.
Measured: Through the study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Sep 2019
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Branko Braam, MD PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929471
- Sponsor's protocol ID
- Pro00086730
- Status last verified
- Feb 2022
- First submitted
- 12 Apr 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03929471
- Acronym / sponsor ID
- Pro00086730
- Conditions
- Fluid Overload, Vascular Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
Title of the study: Target weight correction and vascular stiffness in hemodialysis patients Study design: Randomized clinical trial in the study centre at two locations
Applied medical device:
- Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload.
- Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before, during and after the intervention.
Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the arterial wall stiffness without increasing the prevalence of intradialytic hypotension.
Aim of the study:
- To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements.
- To demonstrate that better fluid volume control is associated with a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) reduction in antihypertensive medications use.
- To show that this approach does not lead to more episodes with intradialytic hypotension.
The number of patients: 70 patients
Detailed description
This study proposal is looking at the application of an accurate assessment of fluid status in hemodialysis (HD) patients to correct fluid overload. Patients undergoing hemodialysis suffer from the inability to maintain their normal body fluids and have a high probability to develop hypertension at initiation of dialysis (1). Long-standing fluid overload is no longer linked solely to high blood pressure, but also to vascular dysfunction and heart failure (1). Fluid overload is estimated based on the amount of fluids available outside the cells (extracellular fluid volume, ECFV). Thus, determination of the right amount of fluid removal during the dialysis depends on the weight of the patient when the ECFV is normal (referred to as Target Weight, TW). Essentially, TW is assessed by routine clinical judgment, for example, leg and hands swelling (edema), elevation in blood pressure and the expansion of the external jugular vein. Unfortunately, this clinical judgment is not reliable to assess fluid status (2, 3); hence, overestimation of TW occurs and leads to fluid overload. Current technology allows assessing fluid overload accurately by using bio-impedance, a non-invasive method that can be easily used in the HD setting. Despite this, very few studies have been reported where a systematic approach was followed to use bio-impedance to correct a TW that has been set too high, with the ultimate goal to correct fluid overload. Therefore, this study aims to provide better fluid control through an intervention to improve fluid status toward normovolemia by using bio-impedance assessment of fluid overload rather than clinical judgments. First, the fluid status will be measured in all study participants by multifrequency bio-impedance using a 'Body Composition Monitor' (BCM, Fresenius). Second, we will divide the study subjects into two groups; the control group which will initially receive standard conventional therapy (no intervention) for 3 months, and the intervention group will undergo by BCM measurements and integrated TW correction protocol for 3 months. Third, after three months, the control group will also involve in the same TW correction adjustment. The Primary outcome is improvement in fluid status towards normovolemia (<1.1 L fluid overload). Secondary outcomes are a) improvement in vascular health as assessed by pulse wave velocity and augmentation index and b) a decrease in the use of antihypertensive medications. Altogether, an optimized fluid status via implemented fluid management plan will provide better control of fluid overload, blood pressure, and improvement in vascular function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Target weight correction protocolPatients to be subjected to a fluid overload correction protocol. |
| Control group | No intervention | –Patient will be followed but no fluid overload correction protocol will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>18 years old) outpatients on 3-4 times per week HD sessions for at least 6 weeks with a life expectancy >6 months.
- Fluid overload ≥1.1L.
- Medically stable patient.
- Minimum of 3 hours of dialysis per session.
Key exclusion criteria (8 listed)
- Pregnancy or lactation.
- Declined informed consent.
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 |
|---|---|---|
| Target weight correction protocolThe intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance). | Other | Intervention group |
Primary outcome
Fluid volume
Time frame: through the study completion, an average of 6 months
Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
3 secondary outcomes
Pulse wave velocity
Time frame: Through the study completion, an average of 6 months
Augmentation index
Time frame: Through the study completion, an average of 6 months
Anti hypertensive medications use
Time frame: Through the study completion, an average of 6 months
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 28 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Fluid Overload
Recruiting
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Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
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.
Branko Braam, MD PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target weight correction protocol in people with Fluid Overload and Vascular Stiffness, run by University of Alberta at 1 site in Canada.
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 4 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 28 Feb 2022. 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 Canada. 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.
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?
Fluid volume (time frame: through the study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2022.