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

NCT02314520 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00000582
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PICC; Central Venous Catheter; Central Line; Neuro ICU; Neuroscience ICU; CVC

Outcome Measures

Primary Outcomes (1)

• Participants With Complications With Central Access Including Insertion

  Aggregation of all complications associated with central access including insertion

  up to 10 weeks

Secondary Outcomes (3)

• Number of Participants With Deep Venous Thrombosis

  up to 10 weeks

• Number of Patients With Complications Related to Insertion

  From the time of insertion until first confirmatory chest X-ray

• Number of Participants With a Central Line Associated Blood Stream Infection

  up to 10 weeks

Study Arms (2)

PICC

ACTIVE COMPARATOR

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

CVC

ACTIVE COMPARATOR

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

Interventions

peripherally inserted central catheter DEVICE

Any complication associated with central access

PICC

centrally inserted central catheter DEVICE

Central access not associated with any complication

CVC

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Dr. J. Christopher Zacko
• Organization: Penn State Health Milton S. Hershey Medical Center Dept of Neurosurgery

jzacko@pennstatehealth.psu.edu

717-531-1279

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 11, 2014
• Study Start: July 13, 2015
• Primary Completion: December 7, 2016
• Study Completion: December 7, 2016
• Last Updated: July 19, 2017
• Results First Posted: July 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)