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

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

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

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* 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

Not Provided

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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