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

NCT01495429 — Phase 3, Completed, 80 participants, University of Michigan

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A Phase III Study of Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care Unit

Registry	NCT01495429, acronym PICNIC
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Actual)
Sponsor	University of Michigan (Other)
Conditions	Venous Thrombosis
Interventions	Central venous catheter (Procedure)
Dates	start 2012-01-01, primary completion 2015-07-01, completion 2015-07-01, first posted 2011-12-20, last updated 2015-08-04
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
PICC line (Peripherally)	Experimental	Procedure: Central venous catheter	placement of a picc line
CICVC (central insertion)	Active comparator	Procedure: Central venous catheter	placement of a centrally inserted central venous catheter

Central venous catheter (Procedure): Placement of a peripherally inserted central venous catheter
Central venous catheter (Procedure): Placement of a centrally inserted central venous catheter

+Outcome measures

Primary outcomes

The composite of death or catheter related large vein thrombosis [15 days]

Secondary outcomes

Cumulative catheter related complications until discharge [30 days]

+Eligibility

Sex: All, ages: 18 Years to any

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* expected to die or have care withdrawn prior to ICU day 7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

+Locations (2)

Facility	City	Country	Status
University of Michigan Health System	Ann Arbor, Michigan	United States
Bronson Methodist Hospital	Kalamazoo, Michigan	United States

+Investigators

Jeffrey J Fletcher, MD, Principal investigator, University of Michigan