Complications Associated With Central Venous Access in the NSICU: PICC vs CVC (NSPVC)

June 21, 2017 updated by: Chris Zacko, Milton S. Hershey Medical Center
The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

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
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

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:

Adult patients admitted to the NSICU, who require central access for the treatment of their illness.

Exclusion Criteria:

  1. Current or recent (within 1 month) diagnosis of bacteremia
  2. Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis
  3. Existing central access
  4. Non-English speaking
  5. Requirement for emergent central access and unable to obtain consent in an emergency setting

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PICC
Patients randomly assigned to receive a peripherally inserted central catheter and they will be monitored for either having a complication or no complication.
Device: peripherally inserted central catheter
Any complication associated with central access
Active Comparator: CVC
Patients randomly assigned to receive a centrally inserted central catheter and they will be monitored for either having a complication or no complication.
Device: centrally inserted central catheter
Central access not associated with any complication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Complications With Central Access Including Insertion
Time Frame: up to 10 weeks
Aggregation of all complications associated with central access including insertion
up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Deep Venous Thrombosis
Time Frame: up to 10 weeks
up to 10 weeks
Number of Patients With Complications Related to Insertion
Time Frame: From the time of insertion until first confirmatory chest X-ray
Any complication of insertion including technical failure
From the time of insertion until first confirmatory chest X-ray
Number of Participants With a Central Line Associated Blood Stream Infection
Time Frame: up to 10 weeks
A Central access associated infection (CLABSI)
up to 10 weeks

Collaborators and Investigators

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

Sponsor

Milton S. Hershey Medical Center

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 (Actual)

July 13, 2015

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

December 7, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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