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Trial record 3 of 5 for:    PICNIC

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495429
First Posted: December 20, 2011
Last Update Posted: August 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey J Fletcher, University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Jeffrey J Fletcher, University of Michigan:

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

Secondary Outcome Measures:
  • Cumulative catheter related complications until discharge [ Time Frame: 30 days ]

Enrollment: 80
Study Start Date: January 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PICC line (Peripherally)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495429


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48103
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49001
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jeffrey J Fletcher, MD University of Michigan
  More Information

Responsible Party: Jeffrey J Fletcher, Study PI, University of Michigan
ClinicalTrials.gov Identifier: NCT01495429     History of Changes
Other Study ID Numbers: HUM00050032
First Submitted: December 13, 2011
First Posted: December 20, 2011
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Jeffrey J Fletcher, 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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases