End Stage Kidney DiseaseNCT01679249
Blood Volume Analysis and Related Outcomes in Hemodialysis
An observational study of End Stage Kidney Disease, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Kidney Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Harbor VA Healthcare System Hemodialysis Unit
New York, New York, 10010
About this study
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.
Read the detailed description
Background: Accurate assessment of the BV and distribution of body fluids is essential for prescribing HD and for reducing complications related to hypovolemia and volume overload. Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method, cannot be used to determine the absolute levels of BV. Here we report the first study of isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator dilutional method.
10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV with an accuracy of ±2.5%, by using <25μCi of iodinated I-131 albumin. It assumes normal BV for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss from the extravascular component of the extracellular space (EV) was calculated by subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were measured by CLM-III during the same HD session. Bland-Altman plot was used to compare relative BV change pre- and post-HD by IBVM and CLM-III.
- Conditions
- End Stage Kidney Disease
- Keywords
- extracellular fluid volume, hypotension, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patients | Stable prevalent patients on 3-times-per-week hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Daxor Corporation
- Responsible party
- Principal investigator, David S. Goldfarb, M.D., VA New York Harbor Healthcare System
- Investigators
- David S Goldfarb, MD, Principal investigator, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679249
- Sponsor's protocol ID
- 01249
- Status last verified
- Sep 2012
- First submitted
- 31 Aug 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume Analysis and Related Outcomes in Hemodialysis
- ClinicalTrials.gov ID
- NCT01679249
- Acronym / sponsor ID
- 01249
- Conditions
- End Stage Kidney Disease
- Keywords
- extracellular fluid volume, hypotension, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Collaborators
- Daxor Corporation
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Accurate assessment of the BV and distribution of body fluids is essential for prescribing HD and for reducing complications related to hypovolemia and volume overload. Monitoring relative changes in BV using hematocrit (Hct), e.g. CLM-III, an indirect method, cannot be used to determine the absolute levels of BV. Here we report the first study of isotope BV measurement (IBVM) for assessing volume status in HD patients using indicator dilutional method.
10 adult HD patients were enrolled in this prospective observational study. Multi-point IBVM before and after HD was performed using BVA-100 (Daxor, New York, NY). BVA-100 calculates BV with an accuracy of ±2.5%, by using <25μCi of iodinated I-131 albumin. It assumes normal BV for a given individual on the basis of patients' deviation from ideal body weight. Fluid loss from the extravascular component of the extracellular space (EV) was calculated by subtracting absolute BV change from total weight loss. Intradialytic relative BV changes were measured by CLM-III during the same HD session. Bland-Altman plot was used to compare relative BV change pre- and post-HD by IBVM and CLM-III.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patients | – | –Stable prevalent patients on 3-times-per-week hemodialysis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood volume measurement and comparison to Crit-Line reading
Time frame: Six months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Goldfarb, MD principal investigator
VA New York Harbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease, run by VA New York Harbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood volume measurement and comparison to Crit-Line reading (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.