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

Tracking Information

First Received Date ^ICMJE

April 7, 2009

Last Updated Date

January 17, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00878033 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

Official Title ^ICMJE

Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Biospecimen

Retention: Samples Without DNA

Description:

Serum Samples will be frozen for later Cytokine Sampling.

Sampling Method

Non-Probability Sample

Study Population

Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.

Condition ^ICMJE

Autonomic Dysfunction
Chronic Renal Failure

Intervention ^ICMJE

Study Group/Cohort (s)

1
Diabetic Dialysis Patients
2
Non-Diabetic Dialysis Patients
3
Healthy Controls

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00878033

Other Study ID Numbers ^ICMJE

UKH-KIMII-001-09

Has Data Monitoring Committee

Responsible Party

Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg

Study Sponsor ^ICMJE

Martin-Luther-Universität Halle-Wittenberg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Matthias Girndt, M.D.

University Hospital Halle, Dept. of Internal Medicine II

Information Provided By

Martin-Luther-Universität Halle-Wittenberg

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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