Influencing Factors of Vancomycin Trough Level in Critically Ill Children With Sepsis

NCT06661772 | Completed

• 1 other identifier: Rc 19-5-2024
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the work will be to measure the vancomycin trough concentration in critically ill children with sepsis in pediatric intensive care unit and its influencing factors.

Conditions

Critically Ill Children; Sepsis

Keywords

Vancomycin Trough Level; Sepsis; Critically ill children

Outcome Measures

Primary Outcomes (1)

• Factors affecting vancomycin trough level

  Influencing factors that can affect Vancomycin therapeutic level

  1 week

Secondary Outcomes (1)

• Treatment failure

  1 month

Study Arms (1)

All pediatric Patients less than 16 years old who were diagnosed with sepsis & admitted to PICU

All consecutively hospitalized children (less than 16 years old) admitted to 30 beds in PICU who were treated with the first course of vancomycin as empirical therapy for suspected sepsis without AKI by the time of the start of treatment were enrolled in the study.

Diagnostic Test: Vancomycin trough concentration method

Interventions

Vancomycin trough concentration method DIAGNOSTIC_TEST

A blood sample for VTL was drawn 30 minutes before administration, prior to the fourth dose of vancomycin, under a complete aseptic technique, unless otherwise ordered by the medical team. Vancomycin serum concentrations were measured using a Human vancomycin ELISA Kit.

All pediatric Patients less than 16 years old who were diagnosed with sepsis & admitted to PICU

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We evaluated the influencing factors that could affect VTL in critically ill children by analyzing VTL in relation to clinical data, other laboratory investigations, dosage and frequency of vancomycin, serum creatinine concentration, CrCL, and e-GFR.

You may qualify if:

• All consecutively hospitalized children (less than 16 years old), who admitted to 30 beds in PICU who were treated with the first course of vancomycin as empirical therapy for suspected sepsis without AKI by the time of the start of treatment were enrolled in the study.

You may not qualify if:

• children who commenced vancomycin for preventive measures, those with a history of multiple vancomycin treatment cycles, individuals showing signs of renal impairment upon initial admission to the PICU based on the pediatric risk, injury, failure, loss, end-stage renal disease (pRIFLE) criterion, and those diagnosed with congenital muscle disorders due to the potential influence of their underlying condition on serum creatinine levels.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Cairo, Al-Qalyubia, 13511, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vancomycin trough levels (Human Vancomycin ELISA Kit) during treatment with at least 48 hours of PICU stay

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 20, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)