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出境医 / 临床实验 / Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
Study Description
Brief 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:
- 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fluid Overload Vascular Stiffness | Other: Target weight correction protocol | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Target Weight Correction and Vascular Stiffness in Hemodialysis Patients |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | June 1, 2020 |
| Estimated Study Completion Date : | July 1, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention group
Patients to be subjected to a fluid overload correction protocol.
|
Other: Target weight correction protocol
The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).
|
|
No Intervention: Control group
Patient will be followed but no fluid overload correction protocol will be applied.
|
Outcome Measures
Primary Outcome Measures :
- Fluid volume [ Time Frame: through the study completion, an average of 6 months ]Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
Secondary Outcome Measures :
- Pulse wave velocity [ Time Frame: Through the study completion, an average of 6 months ]Improvement in pulse wave velocity (millimetre/second)-one of vascular stiffness measurements
- Augmentation index [ Time Frame: Through the study completion, an average of 6 months ]Improvement in augmentation index (%)-one of vascular stiffness measurements
- Anti hypertensive medications use [ Time Frame: Through the study completion, an average of 6 months ]Reduction in the number of anti hypertensive medications use.
Other Outcome Measures:
- Intradialytic hypotensive episodes (IDH) [ Time Frame: Through the study completion, an average of 6 months ]The intervention will not lead to IDH episodes that happen during dialysis treatment. Such episodes including cramps, hypotension, and dizziness.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Contacts
| Contact: Branko Braam, MD PhD | 780-492-1867 | braam@ualberta.ca | |
| Contact: Aya Lafta, MSc Cand | 780-492-1867 | lafta@ualberta.com |
Locations
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2R3 | |
| Contact: Branko Braam, MD phD (780) 492-1867 braam@ualberta.ca | |
| Contact: aya lafta, MSc Cand (780) 492-1867 lafta@ualberta.ca | |
| Sub-Investigator: Aya Lafta, MSc Cand | |
Sponsors and Collaborators
University of Alberta
Investigators
| Principal Investigator: | Branko Braam, MD PhD | University of Alberta |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||||||
| First Posted Date ICMJE | April 26, 2019 | ||||||||
| Last Update Posted Date | November 5, 2019 | ||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Fluid volume [ Time Frame: through the study completion, an average of 6 months ] Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Intradialytic hypotensive episodes (IDH) [ Time Frame: Through the study completion, an average of 6 months ] The intervention will not lead to IDH episodes that happen during dialysis treatment. Such episodes including cramps, hypotension, and dizziness.
|
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Target Weight Correction and Vascular Stiffness in Hemodialysis Patients | ||||||||
| Official Title ICMJE | Target Weight Correction and Vascular Stiffness in Hemodialysis Patients | ||||||||
| Brief 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:
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:
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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE |
|
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| Intervention ICMJE | Other: Target weight correction protocol
The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
70 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 1, 2020 | ||||||||
| Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03929471 | ||||||||
| Other Study ID Numbers ICMJE | Pro00086730 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Alberta | ||||||||
| Study Sponsor ICMJE | University of Alberta | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Alberta | ||||||||
| Verification Date | October 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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