NCT01165411

Brief Summary

It has been estimated that 90% of bloodstream infections associated with catheters, are due to CVCs, and that 500 to 4,000 patients in the United States die annually due to these bloodstream infections. The risk of central line associated bloodstream infections is typically expressed as the number of line infections per 1000 catheter days. This study's goal is to develop a uniform CL protocol, updated practice guidelines based on current evidence, and a standard procedural checklist based on CL care bundles recommended by the Institute for Healthcare Improvement. A secondary goal is to create a CL registry to capture and store data relevant to each CL placed throughout the institution. This registry will provide a wealth of data on CL insertions and complications that may be used as a valuable source of information for quality assurance, performance improvement, and research. With the knowledge and information obtained through this registry, educational offerings can be created, and a standardized institutional process for CL insertion can be developed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

6.4 years

First QC Date

July 12, 2010

Last Update Submit

October 13, 2016

Conditions

Infection

Keywords

Central CatheterizationCentral LineDatabaseRegistryRegistries

Outcome Measures

Primary Outcomes (1)

  • Track and store data on central line insertions and complications which may be used as a valuable source of information for quality assurance, performance improvement, and research

    All data elements collected are either part of the standard of care during routine insertion of Central Venous Catheters (CVCs) and Peripheral Inserted Central Catheter (PICCs) or are undergoing process improvement so that they become the standard of care for these lines. The hospital data warehouse will be automatically fed information from multiple existing databases that are maintained within different locations of the hospital. Once merged, data will be transferred into the Horizon Business Insight database for performance improvement, quality assurance, and research purposes.

    At time of complication or infection

Study Arms (1)

Patients with CVCs and PICC lines placed

This group will have either Standard of Care (control) or Process Improvement infection control changes administered.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that have CVCs and PICC lines placed at LVH

You may qualify if:

  • All patients that have CVCs and PICC lines placed at LVH.

You may not qualify if:

  • The patient has a CVC or PICC that was placed outside of LVHN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18102, United States

Location

Related Publications (3)

  • Mermel LA. Prevention of intravascular catheter-related infections. Ann Intern Med. 2000 Mar 7;132(5):391-402. doi: 10.7326/0003-4819-132-5-200003070-00009.

    PMID: 10691590BACKGROUND

  • DerGurahian J. 5 million lives campaign hits midway point . . . but Institute for Healthcare Improvement officials say it's hard to judge progress. Mod Healthc. 2007 Dec 17;37(50):12-3. No abstract available.

    PMID: 18203368BACKGROUND

  • Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115.

    PMID: 17192537BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

  • Valerie A Rupp, RN, BSN

    Lehigh Valley Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of EM Research

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 19, 2010

Study Start

August 1, 2008

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)