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

Central Venous Catheter Colonisation: Prevalence and Associated Factors Among Critically Ill Patients Admitted to Ugandan Intensive Care Units

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Acute Liver Failure; Head Injury; Post-cardiac Surgery; Post-Cardiorespiratory Arrest Coma; Hypoxic Brain Damage; Diabetic Ketoacidotic Hyperglycaemic Coma

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.

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 48 hours after removal of central venous catheter
Factors associated with central venous catheter colonisation	Factors that have a significant p-value < 0.5 of association with central venous catheter colonisation	up to 14 days

Collaborators and Investigators

• Sponsor: Makerere University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2016
• Primary Completion (ACTUAL): April 10, 2017
• Study Completion (ACTUAL): April 19, 2017

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Liver Diseases; Trauma, Nervous System; Signs and Symptoms, Respiratory; Unconsciousness; Consciousness Disorders; Hypoxia; Liver Failure; Brain Injuries; Craniocerebral Trauma; Hypoxia, Brain; Liver Failure, Acute; Coma
• Other Study ID Numbers: CVC Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No