HemodialysisNCT01814254
Comparison of Body Hydration State in Hemodialysis Patients
An observational study of Hemodialysis and Chronic Kidney Disease, run by Renal Research Institute at 1 site in United States.
Trial summary
Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis, Chronic Kidney Disease
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis clinics
Who may be able to join
- Clinically stable
Who cannot join
- Implants including pacemakers, implantable pumps, artificial joints
- Limb amputations
- Pregnancy
- Simultaneous participation in another clinical study except observational trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Body Hydration State in Hemodialysis Patients With the Hydra 4200 and ZOE (100 and 5 kHZ) Bioimpedance Devices
Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice.
The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA.
The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.
- Conditions
- Hemodialysis, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
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 |
|---|---|---|
| Receiving hemodialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf bioimpedance measurement
Measured: 2 dialysis treatments within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Change of Institutional Affiliation \& Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814254
- Sponsor's protocol ID
- 063-11
- Status last verified
- Feb 2016
- First submitted
- 15 Mar 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Body Hydration State in Hemodialysis Patients With the Hydra 4200 and ZOE (100 and 5 kHZ) Bioimpedance Devices
- ClinicalTrials.gov ID
- NCT01814254
- Acronym / sponsor ID
- 063-11
- Conditions
- Hemodialysis, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change of Institutional Affiliation \& Funding
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Mar 2013 (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.
Estimation of hydration state in dialysis patients is a major challenge in clinical practice. Although many methods have been studied, none have been established yet for clinical routine practice.
The investigators have developed a method, using segmental and calf bioimpedance spectroscopy (cBIS) techniques to measure body hydration. The device we used based on the FDA-approved Hydra 4200 (Xitron Technologies, San Diego, CA). The Hydra 4200 was initially developed to measure whole body and segmental body fluid volumes but Hydra is approved only for measuring healthy subjects. The cBIS monitors hydration state by continuously measuring change in resistance and resistivity in the calf during hemodialysis (HD) or it can be used for simple measurement before, during and after dialysis. Preliminary results in clinical studies have shown that optimal hydration state of HD patients may be determined by the calf method. This study aims to compare the Hydra 4200 to two other devices: the FDA approved ZOE (100 kHz) Fluid Status Monitor (Noninvasive Medical Technologies, Inc, Las Vegas) and a modified version ZOE 5 kHz. The modified ZOE monitor (ZOE (5 kHz)) delivers frequency of 5 kHz and 0.8 mA current instead of 100 kHz and 2 mA.
The subjects of this study include a group of hemodialysis patients and a group of healthy controls. The healthy controls are used to identify a normal range within the healthy population for each method. Each hemodialysis patient will be studied twice in different hydration state. The study will not change the procedure of the patient's dialysis treatment. Since all devices are based on noninvasive bioimpedance technique, this study has minimal risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving hemodialysis | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis clinics
Key inclusion criteria (1 listed)
- Clinically stable
Key exclusion criteria (4 listed)
- Implants including pacemakers, implantable pumps, artificial joints
- Limb amputations
- Pregnancy
- Simultaneous participation in another clinical study except observational trials.
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
Calf bioimpedance measurement
Time frame: 2 dialysis treatments within 1 week
Results and safety
The study was stopped early (reason given: Change of Institutional Affiliation \& Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Peter Kotanko, MD principal investigator
Renal Research Institute
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 Hemodialysis and Chronic Kidney Disease, run by Renal Research Institute 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 24 Feb 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 was stopped early (reason given: Change of Institutional Affiliation \& Funding). Results are not available in the source record.
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?
Calf bioimpedance measurement (time frame: 2 dialysis treatments within 1 week). 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 24 Feb 2016.