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

NCT ID: NCT01495429

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PICC line (Peripherally)

placement of a picc line

Group Type: EXPERIMENTAL

Central venous catheter

Intervention Type: PROCEDURE

Placement of a peripherally inserted central venous catheter

CICVC (central insertion)

placement of a centrally inserted central venous catheter

Group Type: ACTIVE_COMPARATOR

Central venous catheter

Intervention Type: PROCEDURE

Placement of a centrally inserted central venous catheter

Interventions

Central venous catheter

Placement of a peripherally inserted central venous catheter

Intervention Type: PROCEDURE

Central venous catheter

Placement of a centrally inserted central venous catheter

Intervention Type: PROCEDURE

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• expected to die or have care withdrawn prior to ICU day 7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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey J Fletcher

Study PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey J Fletcher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Countries

United States

Other Identifiers

HUM00050032

Identifier Type: -

Identifier Source: org_study_id