Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

May 27, 2019 updated by: Guerkan SENGOELGE, Medical University of Vienna
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1180
        • Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients with thoracic central venous occlusion requiring vascular access

Description

Inclusion Criteria:

  • Patients with thoracic central venous occlusion

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
inside-out-access technique with inside-out access device
Procedure: inside-out-access technique with inside-out access device (Surfacer (R))
inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)
access technique including Sharp recanalization
Procedure: access technique including Sharp recanalization
access technique with Sharp recanalization via interventional radiology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of dialysis access
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure related complications
Time Frame: 3 months
infections, bleeding, hematoma or pericardial effusions and intervention related parameters
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gürkan Sengölge, Department of Medicine III, Division of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vienna-DialysisAccess

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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