NCT00878033

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

April 7, 2009

Last Update Submit

March 9, 2017

Conditions

Autonomic DysfunctionChronic Renal Failure

Study Arms (3)

1

Diabetic Dialysis Patients

2

Non-Diabetic Dialysis Patients

3

Healthy Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Publications (1)

  • Seibert E, Zohles K, Ulrich C, Kluttig A, Nuding S, Kors JA, Swenne CA, Werdan K, Fiedler R, Girndt M. Association between autonomic nervous dysfunction and cellular inflammation in end-stage renal disease. BMC Cardiovasc Disord. 2016 Nov 3;16(1):210. doi: 10.1186/s12872-016-0385-1.

    PMID: 27809785DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Samples will be frozen for later Cytokine Sampling.

MeSH Terms

Conditions

Primary DysautonomiasKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Girndt, M.D.

    University Hospital Halle, Dept. of Internal Medicine II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. habil. Matthias Girndt, Director, Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

DE(1)