Central Venous Catheter Colonisation Among Critically Ill Patients in 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.

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Key information

Conditions

Sepsis Acute Liver Failure Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Diabetic Ketoacidotic Hyperglycaemic Coma Digestive System Diseases Head Injury Hepatic Insufficiency Hypoxia Hypoxia, Brain Hypoxic Brain Damage Infections Inflammation Liver Diseases Liver Failure Liver Failure, Acute Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Cardiorespiratory Arrest Coma Post-cardiac Surgery Septic Shock Shock Shock, Septic Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Prevalence of central venous catheter colonisation

Time frame: up to 14 days

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

Secondary outcomes

Prevalence of Central venous catheter associated bloodstream infections

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

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

Time frame: up to 14 days

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

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 1, 2017
Registry last updated: Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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