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

Venous Thrombosis Clinical Trial

— PICNIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495429
• Other study ID #: HUM00050032
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2011
• Last updated: August 3, 2015
• Start date: January 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• expected to die or have care withdrawn prior to ICU day 7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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of death or catheter related large vein thrombosis		15 days	Yes
Secondary	Cumulative catheter related complications until discharge		30 days	Yes