Autonomic DysfunctionNCT00878033
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
An observational study of Autonomic Dysfunction and Chronic Renal Failure, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomic Dysfunction, Chronic Renal Failure
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Dec 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.
Who may be able to join
- Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis
- Age >18 years
- Sinus action in EKG
- Patient capable for informed consent
- Written and signed informed consent
Who cannot join
- Clinical overt signs of infections of any kind
- Active malign disease
- CRP levels above 50 mg/L
- Cardiac Pace Maker
- Atrial Fibrillation
- Refusal of informed consent
- Cardiac Transplantation
- Immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II
Halle, Saxony-Anhalt, 06120
About this study
This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.
- Conditions
- Autonomic Dysfunction, Chronic Renal Failure
- Medical subject headings
- Primary Dysautonomias, Kidney Failure, 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 |
|---|---|---|
| 1 | Diabetic Dialysis Patients | |
| 2 | Non-Diabetic Dialysis Patients | |
| 3 | Healthy Controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic DysfunctionStudies 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
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Matthias Girndt, M.D., Principal investigator, University Hospital Halle, Dept. of Internal Medicine II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878033
- Sponsor's protocol ID
- UKH-KIMII-001-09
- Status last verified
- Mar 2017
- First submitted
- 7 Apr 2009
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Seibert E, Zohles K, Ulrich C, Kluttig A, Nuding S, Kors JA, Swenne CA, Werdan K, Fiedler R, Girndt M. Association between autonomic nervous dysfunction and cellular inflammation in end-stage renal disease. BMC Cardiovasc Disord. 2016 Nov 3;16(1):210. doi: 10.1186/s12872-016-0385-1.
PubMed 27809785
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00878033
- Acronym / sponsor ID
- UKH-KIMII-001-09
- Conditions
- Autonomic Dysfunction, Chronic Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Apr 2009 (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.
This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetic Dialysis Patients |
| 2 | – | –Non-Diabetic Dialysis Patients |
| 3 | – | –Healthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.
Key inclusion criteria (5 listed)
- Chronic Kidney Disease Stadium KDIGO 5D for at leat 3 months on Dialysis
- Age >18 years
- Sinus action in EKG
- Patient capable for informed consent
- Written and signed informed consent
Key exclusion criteria (8 listed)
- Clinical overt signs of infections of any kind
- Active malign disease
- CRP levels above 50 mg/L
- Cardiac Pace Maker
- Atrial Fibrillation
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
Not reported in the source record.
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 Mar 2017.
- Derived from this study: PubMed 27809785Seibert E, Zohles K, Ulrich C, Kluttig A, Nuding S, Kors JA, Swenne CA, Werdan K, Fiedler R, Girndt M. Association between autonomic nervous dysfunction and cellular inflammation in end-stage renal disease. BMC Cardiovasc Disord. 2016 Nov 3;16(1):210. doi: 10.1186/s12872-016-0385-1.
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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.
Matthias Girndt, M.D. principal investigator
University Hospital Halle, Dept. of Internal Medicine II
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 Autonomic Dysfunction and Chronic Renal Failure, run by Martin-Luther-Universität Halle-Wittenberg 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 5 inclusion and 8 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 Mar 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878033, which also lists 1 linked publication.
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 Mar 2017.