NCT03270774

Brief Summary

Background: Central Venous catheter insertion technique and indwelling time are major risk factors for CVC colonisation. Colonisation occurs through microbial migration and biofilm formation along the catheter insertion tract. This study set out to determine the prevalence and associated factors for central venous catheter colonisation among critically ill patient. No data exists in this clinical setting addressing this topic. Methods: The study population included 100 participants with central venous catheters in situ for at least 24 hours. Catheter tip (distal 5-cm segment) and blood cultures (10mls peripheral blood) were obtained at the time of catheter removal.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

August 30, 2017

Last Update Submit

August 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of central venous catheter colonisation

    Of the patients that had central venous catheter inserted, how many of them developed central venous catheter colonisation

    up to 14 days

Secondary Outcomes (2)

  • Prevalence of Central venous catheter associated bloodstream infections

    Up to 48 hours after removal of central venous catheter

  • Factors associated with central venous catheter colonisation

    up to 14 days

Eligibility Criteria

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

Study population All the critically ill patients with CVCs admitted to the general ICUs in the 4 hospitals above during the study period and who met the inclusion criteria

You may qualify if:

  • Patients of all age groups were included in this study
  • All critically ill patients admitted to the ICU with Central Venous Catheters in situ
  • Written informed consent/assent
  • Waiver of consent for unconscious patients with no attendant/valid surrogate respondent to provide the required information

You may not qualify if:

  • Patients who were already on treatment for CVC-related infectious complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SepsisShock, SepticCraniocerebral TraumaHypoxia, BrainLiver Failure, Acute

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain DiseasesCentral Nervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

April 19, 2016

Primary Completion

April 10, 2017

Study Completion

April 19, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08