Impact of Blood Culture Positivity Time on Clinical Management of Pediatric ICU Patients

NCT05507957 | Unknown DMC

• 1 other identifier: fatma elnaggar
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (4)

• Evaluate the impact of blood culture positivity time in patient management and reduction of ICU stay, as well as decreases in 30-days mortality.

  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

  through study completion, an average of 1 year.

• Investigates the probability of blood culture positivity after 24 hours.

  time of positivity of blood culture measured in hours. It was calculated as the time from the start of incubation to a positive signal

  through study completion, an average of 1 year.

• evaluate if there was diagnostic value of TTP

  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

  through study completion, an average of 1 year.

• Identify if there is difference in the blood culture contamination rate between uses of various type of antiseptic.

  Identify if there is a difference in the blood culture contamination rate (measured in percentage) between uses of various types of antiseptic.

  through study completion, an average of 1 year.

Secondary Outcomes (1)

• - 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.

Interventions

direct reporting of time to positivity of blood culture to ICU to know its effect to patients managment DIAGNOSTIC_TEST

-Disinfection using povidone-iodine, alcohol preparation or chlorhexidine gluconate ethanol (CHG-ALC ), so that each type was used on 40 patients

Also known as: use different type of disinfectants (povidone iodine (PVI), alcohol preparations, and chlorhexidine gluconate ethanol (CHG-ALC)

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.)

You may qualify if:

• 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

You may not qualify if:

• blood culture bottles that were drawn in vacation days (because of no distinct control on transportation time, which affect TTP)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, 71511, Egypt

Location

Related Publications (1)

• endnote

  RESULT

Related Links

• Seasonal variations in blood culture numbers and time to positivity and potential impact of reducing incubation periods
• Time to positivity of blood cultures in patients with bloodstream infections: A useful prognostic tool
• Neither Blood Culture Positivity nor Time to Positivity Is Associated With Mortality Among Patients Presenting With Severe Manifestations of Sepsis: The FABLED Cohort Study
• Chlorhexidine alcohol versus povidone-iodine: The comparative study of skin disinfectants at the blood transfusion centers of Iran

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• mohammed Z Abo krisha, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

fatma s elnaggar, master

CONTACT

+201065074152; hythamfatma142@yahoo.com

amal m hosni, doctora

CONTACT

00201026122444; amal.alameldin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master of clincical patholofy

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

EG (1)