Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT03929471|
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Target Weight Correction and Vascular Stiffness in Hemodialysis Patients|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
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.
- Fluid volume [ Time Frame: through the study completion, an average of 6 months ]Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929471
|Contact: Branko Braam, MD PhDfirstname.lastname@example.org|
|Contact: Aya Lafta, MSc Candemail@example.com|
|University of Alberta||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2R3|
|Contact: Branko Braam, MD phD (780) 492-1867 firstname.lastname@example.org|
|Contact: aya lafta, MSc Cand (780) 492-1867 email@example.com|
|Sub-Investigator: Aya Lafta, MSc Cand|
|Principal Investigator:||Branko Braam, MD PhD||University of Alberta|