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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02314520
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Chris Zacko, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
PICC Central Venous Catheter Central Line Neuro ICU Neuroscience ICU CVC Device: peripherally inserted central catheter Device: centrally inserted central catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Complications Associated With Central Venous Access in the NSICU: PICC vs CVC
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : December 7, 2016
Actual Study Completion Date : December 7, 2016

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




Primary Outcome Measures :
  1. Participants With Complications With Central Access Including Insertion [ Time Frame: up to 10 weeks ]
    Aggregation of all complications associated with central access including insertion


Secondary Outcome Measures :
  1. Number of Participants With Deep Venous Thrombosis [ Time Frame: up to 10 weeks ]
  2. 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

  3. Number of Participants With a Central Line Associated Blood Stream Infection [ Time Frame: up to 10 weeks ]
    A Central access associated infection (CLABSI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314520


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center

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Responsible Party: Chris Zacko, Assistant Professor of Neurosurgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02314520     History of Changes
Other Study ID Numbers: STUDY00000582
First Posted: December 11, 2014    Key Record Dates
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No