Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality.
研究概览
简要总结
Sepsis accounts for high morbidity and mortality rates in ICU globally. Early recognition of sepsis with appropriate antimicrobial therapy is critical for the appropriate management of patients (1).
Blood culture (BC) is considered the gold standard for sepsis etiological diagnosis , with good sensitivity ,but suffering usually of delay or even failure to detect microorganisms in patients already treated with antimicrobials and failure to identify pathogens other than bacteria or yeast (2, 3).
Time-to-positivity (TTP) of blood cultures is defined as the time from the start of incubation to a positive signal. Knowledge of the distribution of blood culture TTP is of clinical benefit in the re-evaluation of patients with a clinical syndrome consistent with infection. A low probability of bacteremia when blood cultures have remained negative after 24 hours (4). Positive episodes with TTP more than or equal 24 h are commonly optimally treated infections, catheter-related infections, or infections caused by slowly growing microorganisms such as Candida or anaerobic Gram-negative bacteria. Growth of multidrug-resistant Gram-negative bacilli is exceptional beyond 24 h. In current clinical practice, bacteremia is considered unlikely if blood cultures have been negative for 48-72 hours (5, 6). Most blood culture bottles turn positive in less than 4 days, shortening the duration of incubation appears the most relevant solution in order to free additional capacity(4).
Various disinfectants, such as povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC), are used for disinfection prior to blood culture sampling. Contamination rates of cultured blood samples vary according to the disinfectant used, sampling site, definition of contamination, and skill level of individuals performing the venipuncture.(7, 8)
In this study, Investigators assessed the real life clinical impact on septic ICU patients based on time of blood culture positivity time.
详细描述
Aim(s) of the Research :
- Evaluate the impact of blood culture positivity time in real -life clinical practice (patient management and reduction of ICU stay, as well as decreases in 30-days mortality.)
- Investigates the probability of blood culture positivity after 24 hours.
- evaluate if there was diagnostic value of TTP
- Identify if there is difference in the blood culture contamination rate between uses of various type of disinfectant.
Sample Size Calculation: 120 septic patient in pediatric intensive care unit
Study tools:
The following will be done to all patients:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The population of our study were patients in ICU unit in pediatric hospital of Assuit University Hospitals, that presented with clinical symptoms which may lead to a suspicion of a bloodstream infection or sepsis which is:
- •Undetermined fever ( ≥ 38°C) or hypothermia ( ≤ 36°C).
- •Shock, chills, rigors
- •Severe local infections (meningitis, endocarditis, pneumonia, pyelonephritis, intra-abdominal suppuration etc.) Multiple episodes of bacteremia per patient were allowed if the antimicrobial therapy for the previous episode had been completed and clinical and microbiological cure had been achieved
排除标准
- •blood culture bottles that were drawn in vacation days (because of no distinct control on transportation time, which affect TTP)
结局指标
主要结局
Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality.
时间窗: through study completion, an average of 1 year.
investigators measured the time to positivity of blood culture in hours. Then direct reporting the result to the physician ( as few true bloodstream infections were detected after 48 hours) ,,, Then study the impact of the result on therapeutic decisions (start of treatment, or switch or association of antibiotic/antifungal therapy). Then days of hospital stay were measured in the day unit\& mortality rate was measured in percentage
Investigates the probability of blood culture positivity after 24 hours.
时间窗: through study completion, an average of 1 year.
time of positivity of blood culture measured in hours. It was calculated as the time from the start of incubation to a positive signal
evaluate if there was diagnostic value of TTP
时间窗: through study completion, an average of 1 year.
see if there was a relationship between time of positivity of blood culture (in hour unit) and the type of microorganism,, and And if TTP can distinguish between contaminant and true pathogen
Identify if there is difference in the blood culture contamination rate between uses of various type of antiseptic.
时间窗: through study completion, an average of 1 year.
Identify if there is a difference in the blood culture contamination rate (measured in percentage) between uses of various types of antiseptic.
次要结局
- - Identify if TTP in real life was superior to expensive modern microbiological techniques for the diagnosis of sepsis(through study completion, an average of 1 year.)
研究者
Fatma Salah EL-Dein Hosney
master of clincical patholofy
Assiut University