Back to resultsPeripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care (PICNIC)
Primary Purpose
Venous Thrombosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Central venous catheter
Central venous catheter
Sponsored by
About this trial
This is an interventional treatment trial for Venous Thrombosis focused on measuring catheter related large vein thrombosis, upper extremity deep venous thrombosis, central venous catheters, upper extremity catheter related large vein thrombosis
Eligibility 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- expected to die or have care withdrawn prior to ICU day 7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
Sites / Locations
- University of Michigan Health System
- Bronson Methodist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PICC line (Peripherally)
CICVC (central insertion)
Arm Description
placement of a picc line
placement of a centrally inserted central venous catheter
Outcomes
Primary Outcome Measures
The composite of death or catheter related large vein thrombosis
Secondary Outcome Measures
Cumulative catheter related complications until discharge
Full Information
NCT ID
NCT01495429
First Posted
December 13, 2011
Last Updated
August 3, 2015
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01495429
Brief Title
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care
Acronym
PICNIC
Official Title
A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis
Keywords
catheter related large vein thrombosis, upper extremity deep venous thrombosis, central venous catheters, upper extremity catheter related large vein thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PICC line (Peripherally)
Arm Type
Experimental
Arm Description
placement of a picc line
Arm Title
CICVC (central insertion)
Arm Type
Active Comparator
Arm Description
placement of a centrally inserted central venous catheter
Intervention Type
Procedure
Intervention Name(s)
Central venous catheter
Intervention Description
Placement of a peripherally inserted central venous catheter
Intervention Type
Procedure
Intervention Name(s)
Central venous catheter
Intervention Description
Placement of a centrally inserted central venous catheter
Primary Outcome Measure Information:
Title
The composite of death or catheter related large vein thrombosis
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Cumulative catheter related complications until discharge
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Fletcher, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care
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