End Stage Renal Failure on DialysisNCT02717533
Blood Volume Analysis and Renal Outcomes in Hemodialysis
An observational study of End Stage Renal Failure on Dialysis and Actual Impaired Fluid Volume, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Actual Impaired Fluid Volume, Kidney Failure
- What is being tested?
- dry weight adjustment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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: Hemodialysis patients
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
- Kidney transplantation
- Malignancy requiring chemotherapy
- Unmeasurable blood pressure with a sphygmomanometer
Show all 10Show fewer
- 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
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.
Read the detailed description
In the first study the investigators demonstrated that BV measurement using BVA-100 is useful to determine absolute BV as well as changes in BV and correlates reasonably well with CLM-III measurements. Individual refilling ability can be determined as well. This may prove useful in prescribing and monitoring ultrafiltration rates, establishment of optimal BV in HD patients and reducing morbidity and mortality associated with chronic HD.
In the current study the investigators hypothesize that BVA can be used in the longer term to evaluate the adequacy of the current clinically estimated dry weight in dialysis patients and can be used to titrate EDW in order to improve overall volume status and decrease the incidence of blood volume misinterpretation. The investigators enrolled 12 eligible patients. Participants underwent post-hemodialysis blood volume analysis (BVA) as a baseline measurement. Based on their Blood Volume (BV) status, their prescribed estimated dry weight (EDW) was adjusted. After 3 to 6 months, participants underwent a repeat BV measurement. The investigators compared the second value to the first in order to judge whether an improvement in BV status occurred if the dry weight prescription was changed, or to judge stability if it was not.
- Being tested
- dry weight adjustment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry weight adjustmentOther
dry weight change to match ideal blood volume obtained by blood volume measurement.
| Study group | Role | What they receive |
|---|---|---|
| blood volume | dry weight adjusted according to ideal blood volume obtained from absolute blood volume measurement (Daxor) Receives: Other: dry weight adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Incidence of dialysis complications and BV as determined by BVA
Dialysis complications that are under investigation include intradialytic hypotension and cramps. The investigators compare the incidence of dialysis complications for patients across subgroups of BV status as determined by BVA. We will also compare the incidence of dialysis complication at baseline and at the second measurement
Measured: 6 months
Change in BV as determined by Crit-Line Monitor and reaching ideal BV by BVA
For every patient the investigators record the relative change in BV as determined by Crit-line monitoring. The investigators compare the relative BV change in patients who are euvolemic by BVA to those who are considered to be volume depleted and to the ones that are volume overloaded
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- 12 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717533
- Sponsor's protocol ID
- 01249-B
- Status last verified
- Mar 2016
- First submitted
- 4 Feb 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
Publications
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.
PubMed 24262029Malha 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.
PubMed 30744587
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume Analysis and Renal Outcomes in Hemodialysis
- ClinicalTrials.gov ID
- NCT02717533
- Acronym / sponsor ID
- 01249-B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Collaborators
- Daxor Corporation
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Mar 2016 (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.
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.
Detailed description
In the first study the investigators demonstrated that BV measurement using BVA-100 is useful to determine absolute BV as well as changes in BV and correlates reasonably well with CLM-III measurements. Individual refilling ability can be determined as well. This may prove useful in prescribing and monitoring ultrafiltration rates, establishment of optimal BV in HD patients and reducing morbidity and mortality associated with chronic HD.
In the current study the investigators hypothesize that BVA can be used in the longer term to evaluate the adequacy of the current clinically estimated dry weight in dialysis patients and can be used to titrate EDW in order to improve overall volume status and decrease the incidence of blood volume misinterpretation. The investigators enrolled 12 eligible patients. Participants underwent post-hemodialysis blood volume analysis (BVA) as a baseline measurement. Based on their Blood Volume (BV) status, their prescribed estimated dry weight (EDW) was adjusted. After 3 to 6 months, participants underwent a repeat BV measurement. The investigators compared the second value to the first in order to judge whether an improvement in BV status occurred if the dry weight prescription was changed, or to judge stability if it was not.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood volume | – | Other: dry weight adjustmentdry weight adjusted according to ideal blood volume obtained from absolute blood volume measurement (Daxor) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients
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 (10 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
- Kidney transplantation
- Malignancy requiring chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry weight adjustmentdry weight change to match ideal blood volume obtained by blood volume measurement. | Other | blood volume |
Primary outcome
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
Time frame: 6 months
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
Serial measurements of absolute blood volume 3-6 months apart to achieve the target DW at which post-HD BV equals ideal BV
Time frame: 6 months
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
2 secondary outcomes
Incidence of dialysis complications and BV as determined by BVA
Time frame: 6 months
Change in BV as determined by Crit-Line Monitor and reaching ideal BV by BVA
Time frame: 6 months
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 23 Mar 2016.
- Results publication: PubMed 24262029Puri 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.
- Derived from this study: PubMed 30744587Malha 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Failure on Dialysis and Actual Impaired Fluid Volume, 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 10 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 23 Mar 2016. 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?
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 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717533, which also lists 2 linked publications.
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 23 Mar 2016.