NCT03344627

Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

Conditions

• Sepsis
• Septic Shock
• Critical Illness
• Carbapenem
• Pharmacokinetic
• Pharmacodynamic
• Clinical Outcome
• Organ Failure, Multiple
• Morality

Interventions

Type	Name	Description
DRUG	Meropenem standard dose	* Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection.
DRUG	Meropenem high dose	* Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours. * Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-11-30
• Completion: 2018-12-31
• First posted: 2017-11-17
• Last updated: 2019-03-12

Locations

1 site across 1 country: Thailand