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Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00878033
First received: April 7, 2009
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition
Autonomic Dysfunction
Chronic Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Biospecimen Retention:   Samples Without DNA

Serum Samples will be frozen for later Cytokine Sampling.


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diabetic Dialysis Patients
2
Non-Diabetic Dialysis Patients
3
Healthy Controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 7, 2009
Last Updated: January 17, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Inflammation
Kidney Failure, Chronic
Renal Insufficiency
Pathologic Processes
 Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013