Clinical outcomes of pharmacokinetic and pharmacodynamic meropenem dosing in critically ill patients with sepsis or septic shock

Phase 3

Recruiting

• Conditions: Clinical outcomes of pharmacokinetic and pharmacodynamic meropenem dosing in critically ill patients with sepsis or septic shock is not founded. In addition, Phra Phutthabat Hospital used meropenem in large quantities.; meropenem, bacteria infection, mSOFA, sepsis, septic shock

• Registration Number: TCTR20220106001
• Lead Sponsor: Silpakorn university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. 18 years and older
2. The patient is diagnosed with sepsis or septic shock who receive meropenem during 72 hours after diagnosis sepsis and 24 hours after diagnosis septic shock.
3. Patients have characteristics at least two of the following.
3.1 Patient is diagnosed with sepsis or SOFA and qSOFA scores greater than or equal 2 points.
3.2 Patient is diagnosed with sepsis shock or received vasopressors or mean arterial pressure less than 65 mm Hg and lactate greater than 2 mmol/L.
3.3 Patient admits to the intensive care unit.
4. Patient founds at least 1 in 4 sources of infection.
4.1 lungs
4.2 Abdominal
4.3 urinary tract
4.4 Blood
5. Patient signs inform consent to participate in prospective study.

Exclusion Criteria

1. Patient is received meropenem for less than 3 days.
2. Patient have a history of receiving meropenem within 1 week prior to recruitment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
deltamSOFA score 28 day The mSOFA score combines a clinical assessment of 2 organ systems, cardiovascular system and central nervous system, with laboratory measurements for evaluation of 4 other organ systems.,14 and 28 day mortality 14 and 28 day stay or death

Secondary Outcome Measures

Name	Time	Method
Ventilator free day During ICU stay or death or maximun of 28 days Day alive and free of mechanical ventilator,Vasopressor free day During ICU stay or death or maximun of 28 days Day alive and free of vasopressor,ICU free day During ICU stay or death or maximun of 28 days Day alive and not stay in ICU,Hospital free day During ICU stay or death or maximun of 28 days Day alive and not stay in hospital