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NCT02314520 Clinical Trial

Complications Associated With Central Venous Access in the NSICU: PICC vs CVC

Central Venous Catheter Clinical Trial

— NSPVC  

Official title:
Complications Associated With Central Venous Access in the NSICU: PICC vs CVC

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02314520
Other study ID # STUDY00000582
Secondary ID
Status Completed
Phase N/A
First received November 26, 2014
Last updated May 10, 2017
Start date July 13, 2015
Est. completion date December 7, 2016

Study information
Verified date May 2017
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.

Recruitment information / eligibility
Status Completed
Enrollment 153
Est. completion date December 7, 2016
Est. primary completion date December 7, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Adult patients admitted to the NSICU, who require central access for the treatment of their illness.

Exclusion Criteria:

1. Current or recent (within 1 month) diagnosis of bacteremia

2. Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis

3. Existing central access

4. Non-English speaking

5. Requirement for emergent central access and unable to obtain consent in an emergency setting

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• peripherally inserted central catheter
Any complication associated with central access
• centrally inserted central catheter
Central access not associated with any complication

Locations
Country Name City State
United States Penn State Hershey Medical Center Hershey Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary All cause complications Aggregation of all complications associated with central access including insertion up to 10 weeks
Secondary Deep Venous Thrombosis up to 10 weeks
Secondary Time to complication length of time with line in place required to develop the complication up to 10 weeks
Secondary Insertion related complication Any complication of insertion including technical failure Insertion
Secondary Infection A Central access associated infection (CLABSI) up to 10 weeks
Secondary Mechanical failure A mechanical failure (clot, tear, etc.) of the central access line up to 10 weeks
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