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

NCT ID: NCT03270774

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-19
• Study Completion Date: 2017-04-19

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CVC Study

Identifier Type: -

Identifier Source: org_study_id