Correspondence of ScO2 and Cardiac Output in Hemodialysis | NCT01252394

Studies
Correspondence of ScO2 and Cardiac Output in Hemodialysis

NCT01252394

Sponsor

Danish State Hospital

Status

Unknown status

Last Update Posted

Dec 3, 2010Estimated

Enrollment

37Estimated

Phase

Not provided

Conditions

Hemodialysis

Interventions

Not provided

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Nov 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Dec 2, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

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

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

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

The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Label	Type	Description	Intervention Names
Hemodialysis patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology.

Exclusion Criteria:

Age below 18 years. Failure to give informed consent.

Accepts Healthy Volunteers

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

Hemodialysis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joakim Cordtz, MD	Contact	+45 60 85 93 96		drcordtz@yahoo.dk

Overall Officials

Name	Affiliation	Role
Soeren D Ladefoged, MD	Dep. of Nephrology, Copenhagen University Hospital.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital	Recruiting	Copenhagen E		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18638095	Background	Cordtz J, Olde B, Solem K, Ladefoged SD. Central venous oxygen saturation and thoracic admittance during dialysis: new approaches to hemodynamic monitoring. Hemodial Int. 2008 Jul;12(3):369-77. doi: 10.1111/j.1542-4758.2008.00283.x.

Type	Date	Date Unknown
Release	Apr 27, 2011
Reset	May 24, 2011
Release	Feb 25, 2013
Reset	Apr 5, 2013

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 27, 2011			May 24, 2011
Feb 25, 2013