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CompletedNCT03270774Updated Sep 1, 2017

Central Venous Catheter Colonisation Among Critically Ill Patients in Intensive Care Units

An observational study in Sepsis, Septic Shock and Post-cardiac Surgery, sponsored by Makerere University. Completed. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Makerere University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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.

Read the detailed description

Introduction : Central venous catheter (CVC) insertion technique and time spent in situ (dwell period) are major risk factors for CVC colonisation among patients admitted to intensive care units (ICU) worldwide. Normal skin flora colonizes CVCs early in their dwell period (\< 7-10 days) causing variable occurrence of infections in all categories of patients. Uganda has no data on CVC colonisation and with increasing use there is concern of CVC colonisation and its consequences. This study was done to determine the prevalence and associated factors of CVC colonization among patients in general ICUs.

Methodology: This was prospective cohort study. Critically ill patients with CVCs in situ from four general ICUs were consecutively enrolled into the study. Data on socio-demographic, clinical characteristics (diagnosis, comorbidities) and CVC insertion (site, technique, experience) was collected using a standardised questionnaire until a sample size of 100 was achieved. At the time of CVC removal, the CVC tip (distal 5cm segment) was aseptically obtained and cultured for microorganisms using the semi-quantitative method. A blood culture sample (10mls) was also collected from a peripheral site at the same time. Data was double entered into EPIDATA version 3.1.5 and exported to STATA version 12.0 for analysis.

02

Conditions studied

  • Sepsis
  • Septic Shock
  • Post-cardiac Surgery
  • Post-Cardiorespiratory Arrest Coma
  • Head Injury
  • Hypoxic Brain Damage
  • Acute Liver Failure
  • Diabetic Ketoacidotic Hyperglycaemic Coma
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
05

What researchers measure

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

    Time frame: up to 14 days

Secondary outcomes

  1. Prevalence of Central venous catheter associated bloodstream infections

    Of the patients that developed central venous catheter colonisation, how many of them developed associated bloodstream infection

    Time frame: Up to 48 hours after removal of central venous catheter

  2. Factors associated with central venous catheter colonisation

    Factors that have a significant p-value \< 0.5 of association with central venous catheter colonisation

    Time frame: up to 14 days

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03270774
Lead sponsor
Makerere University
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Apr 19, 2016
Primary completion
Apr 10, 2017
Completion
Apr 19, 2017
Last update
Sep 1, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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