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

NCT01495429 | Completed Phase 3 DMC

• 1 other identifier: HUM00050032
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thrombosis

Keywords

catheter related large vein thrombosis; upper extremity deep venous thrombosis; central venous catheters; upper extremity catheter related large vein thrombosis

Outcome Measures

Primary Outcomes (1)

• The composite of death or catheter related large vein thrombosis

  15 days

Secondary Outcomes (1)

• Cumulative catheter related complications until discharge

  30 days

Study Arms (2)

PICC line (Peripherally)

EXPERIMENTAL

placement of a picc line

Procedure: Central venous catheter

CICVC (central insertion)

ACTIVE COMPARATOR

placement of a centrally inserted central venous catheter

Procedure: Central venous catheter

Interventions

Central venous catheter PROCEDURE

Placement of a peripherally inserted central venous catheter

PICC line (Peripherally)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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• expected to die or have care withdrawn prior to ICU day 7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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

University of Michigan Health System

Ann Arbor, Michigan, 48103, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49001, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Central Venous Catheters

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Jeffrey J Fletcher, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 20, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

US (2)