Blood Volume Analysis and Renal Outcomes in Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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The objective of the proposed study is to demonstrate that serial blood volume analysis (BVA) using RI-BVA (BVA-100, Daxor, NY) can be used to guide changes in prescription of dry weight for hemodialysis patients. The knowledge of a patient's ideal BV and degree of hypervolemia using these measurements can be used to change the prescription of DW in an objective way instead of the current standard of practice, which is based on subjective prescription of dry weight. A first study was conducted to determine the rate of plasma volume (PV) re-expansion for each patient as a guide to rate of fluid removal (results published, refer to citations). A second study was conducted in order to assess the value of a BVA measurement in guiding prescription of clinical DW. A follow up BVA would then be done in order to check if patients were closer to ideal BV than prior to changing dry weight.

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Detailed Description

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In the first study the investigators demonstrated that BV measurement using BVA-100 is useful to determine absolute BV as well as changes in BV and correlates reasonably well with CLM-III measurements. Individual refilling ability can be determined as well. This may prove useful in prescribing and monitoring ultrafiltration rates, establishment of optimal BV in HD patients and reducing morbidity and mortality associated with chronic HD.

In the current study the investigators hypothesize that BVA can be used in the longer term to evaluate the adequacy of the current clinically estimated dry weight in dialysis patients and can be used to titrate EDW in order to improve overall volume status and decrease the incidence of blood volume misinterpretation. The investigators enrolled 12 eligible patients. Participants underwent post-hemodialysis blood volume analysis (BVA) as a baseline measurement. Based on their Blood Volume (BV) status, their prescribed estimated dry weight (EDW) was adjusted. After 3 to 6 months, participants underwent a repeat BV measurement. The investigators compared the second value to the first in order to judge whether an improvement in BV status occurred if the dry weight prescription was changed, or to judge stability if it was not.

Conditions

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End Stage Renal Failure on Dialysis Actual Impaired Fluid Volume Kidney Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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blood volume

dry weight adjusted according to ideal blood volume obtained from absolute blood volume measurement (Daxor)

dry weight adjustment

Intervention Type OTHER

dry weight change to match ideal blood volume obtained by blood volume measurement.

Interventions

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dry weight adjustment

dry weight change to match ideal blood volume obtained by blood volume measurement.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>21 years
* Primary diagnosis of either chronic or acute kidney disease
* Currently receiving HD treatment
* Thrice-weekly or twice-weekly HD schedule
* Treated with standard bicarbonate HD for at least the preceding 6 months

Exclusion Criteria

* Pregnant women or nursing mothers
* Known hypersensitivity to iodine, eggs, albumin or any other component of the Volumex injection kit
* Current enrollment in another investigational treatment protocol for dialysis
* Kidney transplantation
* Malignancy requiring chemotherapy
* Unmeasurable blood pressure with a sphygmomanometer
* Active hematological disease
* Active gastrointestinal bleeding
* Severe malnutrition (predialysis serum albumin \<2.6 g/dL)
* Persistent condition of intradialytic blood pressure instability (hypotensive episodes in \>80% of regular dialysis sessions) within the previous one month period

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No