Blood Volume Analysis and Renal Outcomes in Hemodialysis

NCT02717533 | Completed

• 1 other identifier: 01249-B
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Serial measurements of absolute blood volume before and after a hemodialysis treatment to achieve the target DW at which post-HD BV equals ideal BV

  To demonstrate that serial BVA using the Blood Volume Analyzer (BVA-100) can be used to guide changes in prescription of DW for HD patients in an objective way instead of the current standard of practice, which is based on subjective prescription of dry weight. The results obtained from this first study have been published (see references) and show good correlation with CLM-III measurements and can estimate individual refilling ability

  6 months

• Serial measurements of absolute blood volume 3-6 months apart to achieve the target DW at which post-HD BV equals ideal BV

  To demonstrate that serial BVA using the Blood Volume Analyzer (BVA-100) can be used to guide changes in prescription of DW for HD patients in an objective way so that post-dialysis weight reaches the patient's true dry weight. The other main objective is to study the correlation between change in post-dialysis weights and change in BV status as determined by BVA. This outcome will be looked at for all patients and also in the subgroups of patients who had their dry weight changed according to initial BVA measurement and in patients whose dry weight was kept the same after the initial measurement

  6 months

Secondary Outcomes (2)

• Incidence of dialysis complications and BV as determined by BVA

  6 months

• Change in BV as determined by Crit-Line Monitor and reaching ideal BV by BVA

  6 months

Study Arms (1)

blood volume

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

Other: dry weight adjustment

Interventions

dry weight adjustment OTHER

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

blood volume

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients

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

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead
• Daxor Corporation: collaborator

Study Sites (1)

New York Harbor VA Healthcare System Hemodialysis Unit

New York, New York, 10010, United States

Location

Related Publications (2)

• Puri S, Park JK, Modersitzki F, Goldfarb DS. Radioisotope blood volume measurement in hemodialysis patients. Hemodial Int. 2014 Apr;18(2):406-14. doi: 10.1111/hdi.12105. Epub 2013 Nov 22.

  PMID: 24262029 RESULT

• Malha L, Fattah H, Modersitzki F, Goldfarb DS. Blood volume analysis as a guide for dry weight determination in chronic hemodialysis patients: a crossover study. BMC Nephrol. 2019 Feb 11;20(1):47. doi: 10.1186/s12882-019-1211-7.

  PMID: 30744587 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 23, 2016
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

US (1)