Autonomic Dysfunction and Inflammation in Chronic Hemodia... | NCT00878033

Studies
Autonomic Dysfunction and Inflammation in Chronic Hemodialysis Patients

NCT00878033

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Autonomic Dysfunction
Chronic Renal Failure

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 7, 2009

First Submission Date that Met QC Criteria

Apr 7, 2009

First Posted Date

Apr 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2017

Last Update Posted Date

Mar 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Girndt, Prof. Dr. med. habil. Matthias Girndt, Director, Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II, Martin-Luther-Universität Halle-WittenbergPrincipal Investigator

Lead Sponsor

Martin-Luther-Universität Halle-WittenbergOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Diabetic Dialysis Patients
2		Non-Diabetic Dialysis Patients
3		Healthy Controls

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diabetic and Non-diabetic Dialysis Patients. Healthy Controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Girndt, M.D.	University Hospital Halle, Dept. of Internal Medicine II	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Martin-Luther-Universität Halle-Wittenberg, Dept. of Internal Medicine II		Halle	Saxony-Anhalt	06120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27809785	Derived	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.

ID	Term
D054969	Primary Dysautonomias
D007676	Kidney Failure, Chronic

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency