University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
NCT Number: NCT03929471
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. 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:
1. To demonstrate improvement in fluid status by a target weight correction protocol which applies BCM measurements. 2. 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. 3. To show that this approach does not lead to more episodes with intradialytic hypotension.
The number of patients: 70 patients
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2R3, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).
Time frame: through the study completion, an average of 6 months
Improvement in fluid status towards normovolemia (<1.1 L fluid overload)
Time frame: Through the study completion, an average of 6 months
Improvement in pulse wave velocity (millimetre/second)-one of vascular stiffness measurements
Time frame: Through the study completion, an average of 6 months
Improvement in augmentation index (%)-one of vascular stiffness measurements
Time frame: Through the study completion, an average of 6 months
Reduction in the number of anti hypertensive medications use.
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.
University of Alberta
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06167707
Cardiovascular Diseases, Edema
Tampa, Florida, United States
View Trial DetailsNCT06995144
Cardiovascular Diseases, Chronic Disease
Miami, Florida, United States
View Trial DetailsNCT04914455
Cardiovascular Diseases, Cardiovascular Surgery
Lille, NORD, France
View Trial DetailsNCT05957003
Cardiac Surgery, Edema
Tanta, El Gharbyia, Egypt
View Trial Details