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

August 3, 2015 updated by: Jeffrey J Fletcher, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • University of Michigan Health System
      • Kalamazoo, Michigan, United States, 49001
        • Bronson Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • expected to die or have care withdrawn prior to ICU day 7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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PICC line (Peripherally)
placement of a picc line
Procedure: Central venous catheter
Placement of a peripherally inserted central venous catheter
Procedure: Central venous catheter
Placement of a centrally inserted central venous catheter
Active Comparator: CICVC (central insertion)
placement of a centrally inserted central venous catheter
Procedure: Central venous catheter
Placement of a peripherally inserted central venous catheter
Procedure: Central venous catheter
Placement of a centrally inserted central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite of death or catheter related large vein thrombosis
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative catheter related complications until discharge
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Jeffrey J Fletcher, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00050032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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