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Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00878033
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:
This study investigates the relationship between autonomic dysfunction and chronic inflammation in hemodialysis patients.

Condition or disease
Autonomic Dysfunction Chronic Renal Failure

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients
Study Start Date : April 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Diabetic Dialysis Patients
2
Non-Diabetic Dialysis Patients
3
Healthy Controls



Biospecimen Retention:   Samples Without DNA
Serum Samples will be frozen for later Cytokine Sampling.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878033


Locations
Germany
Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II
Halle (Saale), Saxony-Anhalt, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Matthias Girndt, M.D. University Hospital Halle, Dept. of Internal Medicine II

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthias Girndt, Prof. Dr. med. habil. Matthias Girndt, Director, Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00878033     History of Changes
Other Study ID Numbers: UKH-KIMII-001-09
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Inflammation
Renal Insufficiency
Kidney Failure, Chronic
Autonomic Nervous System Diseases
Primary Dysautonomias
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Nervous System Diseases