Blood Volume Analysis and Renal Outcomes in Hemodialysis

Completed

Conditions studied: End Stage Renal Failure on Dialysis, Actual Impaired Fluid Volume, Kidney Failure

In brief

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.

Key facts

Study ID

NCT02717533

Run by

VA New York Harbor Healthcare System

People needed

12

Starts

2014-01-01

Expected to finish

2015-01-01

Last updated by the study team

2016-03-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York Harbor VA Healthcare System Hemodialysis Unit — New York, New York, United States

Full record on ClinicalTrials.gov

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