Blood Volume Analysis and Related Outcomes in Hemodialysis

NCT01679249 | Completed

• 1 other identifier: 01249
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Kidney Disease

Keywords

extracellular fluid volume; hypotension; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Blood volume measurement and comparison to Crit-Line reading

  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.

  Six months

Study Arms (1)

Hemodialysis patients

Stable prevalent patients on 3-times-per-week hemodialysis

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

Subjects will be recruited from the pool of patients at the Dialysis Center at the Department of Veteran Affairs New York Harbor Healthcare System who are currently undergoing dialysis for treatment of chronic kidney disease.

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
• The need to perform hemodialysis with predilution because this will interfere with measurements of relative blood volume changes (ΔRBV)
• 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

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypotension

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David S Goldfarb, MD

  VA New York Harbor Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 10, 2012

Record last verified: 2012-09

Locations

US (1)