Renal Insufficiency, ChronicNCT00397306
Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
A study testing Bioimpedance Analysis in people with Renal Insufficiency, Chronic, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Bioimpedance Analysis
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Sep 2008
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinically stable on dialysis within the last three months
- signed written informed consent
Who cannot join
- acute myocardial infarction or stroke within the last six months
- heart failure stage NYHA IV
- concommitant participation in other interventional trials
- psychiatric conditions that prevent subject from following the study procedures / protocol
- pregnancy or lactation
- limb amputation
Show all 10Show fewer
- cardiac pacemaker
- joint implants
- implantable pumps and other metallic implants
- For healthy subjects and CKD patients in stages K/DIGO I-IV the above mentioned criteria other than the first mentioned are applicable respectively.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Saarland, Dept. of Internal Medicine IV, Div. of Nephrology and Hypertension
Homburg, Saarland, 66421
About this study
Official title: Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
The purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Bioimpedance Analysis
- 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.
Bioimpedance AnalysisDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance Dry weight
Secondary outcomes (8)
Resistance
Resistivity
Blood pressure
LV Diameter
Shortening Fraction
Wall thickness LA, LV
Quality of Life
EPO-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Investigators
- Eric Seibert, M.D., Principal investigator, University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397306
- Sponsor's protocol ID
- 95/06
- Status last verified
- Apr 2009
- First submitted
- 7 Nov 2006
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of a Bioimpedance Method for Determination of Dry Weight in Dialysis Patients
- ClinicalTrials.gov ID
- NCT00397306
- Acronym / sponsor ID
- 95/06
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Nov 2006 (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 purpose of this study is the evaluation of a bioimpedance method for determination of dry weight in dialysis patients. Additionally normal tissue hydration in non-Dialysis patients is investigated in healthy subjects and patients with chronic kidney disease in stages K/DIGO I-IV
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinically stable on dialysis within the last three months
- signed written informed consent
Key exclusion criteria (10 listed)
- acute myocardial infarction or stroke within the last six months
- heart failure stage NYHA IV
- concommitant participation in other interventional trials
- psychiatric conditions that prevent subject from following the study procedures / protocol
- pregnancy or lactation
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 |
|---|---|---|
| Bioimpedance Analysis | Device | – |
Primary outcome
Bioimpedance Dry weight
8 secondary outcomes
Resistance
Resistivity
Blood pressure
LV Diameter
Shortening Fraction
Wall thickness LA, LV
Quality of Life
EPO-Dose
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 8 Apr 2009.
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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.
Eric Seibert, M.D. principal investigator
University Hospital of Saarland, Department of Internal Medicine IV, Division of Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioimpedance Analysis in people with Renal Insufficiency, Chronic, run by University Hospital, Saarland at 1 site in Germany.
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 2 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 8 Apr 2009. 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 Germany. 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?
Bioimpedance Dry weight. 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 8 Apr 2009.