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Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care (PICNIC)

This study is not yet open for participant recruitment.
Verified December 2011 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jeffrey J Fletcher, University of Michigan Health System
ClinicalTrials.gov Identifier:
NCT01495429
First received: December 13, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.


Condition Intervention Phase
Venous Thrombosis
 Procedure: Central venous catheter
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The composite of death or catheter related large vein thrombosis [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cumulative catheter related complications until discharge [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PICC line
placement of a picc line
 Procedure: Central venous catheter
Placement of a peripherally inserted central venous catheter
Active Comparator: CICVC (central insertion)
placement of a centrally inserted central venous catheter
 Procedure: Central venous catheter
Placement of a centrally inserted central venous catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients age > 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
  • the patients must be expected to survive and need a central venous catheter for at least 7 days.

Exclusion Criteria:

  • prisoner
  • age < 18
  • expected to die or have care withdrawn prior to ICU day 7
  • requiring an emergent central venous catheter
  • suspected bacteremia
  • recent central venous catheter within the last 30 days
  • patients who are not a candidate for bedside placement of either a CICVC or PICC line
  • patients with renal insufficiency with creatinine level greater than 3.0 mg/dL (265.2 m mol/L) or who were undergoing hemodialysis
  • patients requiring a central venous catheter for prolonged antibiotic therapy\
  • patient who the treating clinician feels clearly needs one particular type of catheter over the other
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495429

Contacts
Contact: Jeffrey J Fletcher, MD 734-845-8698 jeffletc@med.umich.edu
Contact: Karen Frisch, BA 734-232-4843 kfrisch@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Not yet recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Jeffrey J Fletcher, MD     734-845-8698     jeffletc@med.umich.edu    
Contact: Karen Frisch, BA     734-763-4768     kfrisch@med.umich.edu    
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jeffrey J Fletcher, MD University of Michigan
  More Information

No publications provided

Responsible Party: Jeffrey J Fletcher, Study PI, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT01495429     History of Changes
Other Study ID Numbers: HUM00050032
Study First Received: December 13, 2011
Last Updated: December 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
catheter related large vein thrombosis
upper extremity deep venous thrombosis
central venous catheters
upper extremity catheter related large vein thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on June 18, 2013