Population Pharmacokinetics of Meropenem in Critically Ill Infant Patients

Not Applicable

Recruiting

• Conditions: Critically ill infant patients; Bacterial Infections; Meropenem

• Registration Number: TCTR20191106001
• Lead Sponsor: The 90th Anniversary of Chulalongkorn University Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-06
• Study Completion: 2020-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients were aged 1 month - 2 years
2. Patients admitted to pediatrics intensive care unit (PICU) or patients admitted to outside the PICU that they were criteria as follows
- Patients had been diagnosed with sepsis
- Patients had been diagnosed with septic shock
- Patients had quick SOFA scores ≥ 2 while receiving the meropenem
- Patients were receiving vasopressor drug while receiving the meropenem
- Patients used invasive mechanical ventilation while receiving the meropenem
3. Patients were receiving meropenem therapy

Exclusion Criteria

1. Patients had meropenem allergy or history meropenem allergy
2. Patients had weight lower 3 kilograms
3. Patients had preterm birth history
4. Patients had creatinine clearance < 50 ml/min/1.73 m2
5. Patients were receiving renal replacement therapy or kidney transplant
6. Patients were receiving drug interaction with meropenem that valproic acid and probenecid
7. Parent of infant patients did not consent to attend research or patients did not have childcare obviously

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of population 0.5 or 1 or 3 h, 2, 4, 6 and 8 h Blood for meropenem level

Secondary Outcome Measures

Name	Time	Method
Severe oxygen desaturation During intubation Pulse oximetry < 80%,Lowest oxygen saturation During intubation up to 2 minutes after successful intubation Pulse oximetry,Hypotension that requires treatment with medication or fluid During intubation Blood pressure measurement,Bradycardia that requires medication During intubation Electrocardiogram monitoring,Cardiac arrest During intubation Electrocardiogram monitoring,Air leak syndrome During and immediately after intubation Chest X&#45;ray showing pneumothorax&#44; pneumomediastinum or pneumoperitoneum,Abdominal distention During and immediately after intubation Physical exam