New York Harbor VA Healthcare System Hemodialysis Unit
New York, 10010, United States
NCT Number: NCT01679249
An understanding of fluid changes that occur during hemodialysis (HD) with ultrafiltration (UF) is essential for determining the efficacy of HD, as well as for reducing complications related to hypovolemia or, conversely, chronic volume overload.
Looking for future studies?
Notify Me21 year and older
All sexes
Observational
New York, 10010, United States
Background: Accurate assessment of the BV and distribution of body fluids is essential for prescribing HD and for reducing complications related to hypovolemia and volume overload. Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method, cannot be used to determine the absolute levels of BV. Here we report the first study of isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator dilutional method.
10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV with an accuracy of ±2.5%, by using <25μCi of iodinated I-131 albumin. It assumes normal BV for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss from the extravascular component of the extracellular space (EV) was calculated by subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were measured by CLM-III during the same HD session. Bland-Altman plot was used to compare relative BV change pre- and post-HD by IBVM and CLM-III.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Six months
To compare the results obtained by two different methods of assessing BV: direct measurement of BV using the Blood Volume Analyzer (BVA-100) vs. indirect measurement of relative changes in BV using the Crit-Line Monitor (CLM III). Blood volume is measured in liters and compared with "ideal blood volume" nomograms. Crit-Line Monitor measures relative change in blood volume as a percentage change and does not have absolute values.
VA New York Harbor Healthcare System
Fed
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.
NCT02513303
Arteriovenous Fistula, Arteriovenous Malformations
Huntsville, Alabama, United States
View Trial DetailsNCT05425056
Arteriovenous Fistula, Arteriovenous Malformations
San Diego, California, United States
View Trial DetailsNCT05836220
Chronic Disease, Disease Attributes
Anaheim, California, United States
View Trial DetailsNCT06581393
Chronic Disease, Disease Attributes
Ontario, California, United States
View Trial Details