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
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 100 is close to the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
•Patients who were already on treatment for CVC-related infectious complications.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
No study locations are listed for this record.
Ran from Apr 2016 to primary completion in Apr 2017, 11 months.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's 11 months is below that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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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