Blood Volume Analysis and Related Outcomes in Hemodialysis

Completed

Conditions studied: End Stage Kidney Disease

In brief

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.

Key facts

Study ID

NCT01679249

Run by

VA New York Harbor Healthcare System

People needed

10

Starts

2012-01-01

Expected to finish

2012-05-01

Last updated by the study team

2012-09-10

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
• 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

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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