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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014