Phase 1
Completed N=8
Imipenem/Cilastatin/Relebactam PK in ECMO
Source: ClinicalTrials.gov NCT04493151 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Imipenem Clearance — 15.21 Liters per hour
Summary
Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Imipenem Clearance |
15.21 | — |
| PRIMARY Relebactam Clearance |
6.95 | — |
| SECONDARY Imipenem Area Under the Curve (AUC) |
36.9 | — |
| SECONDARY Relebactam Area Under the Curve (AUC) |
45.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older;
- On support with Veno-venous- or Veno-arterial-ECMO;
- Documented infection or presumed infection as confirmed by the presence of at least one of the following criteria within the past 72 hours:
- Documented fever (oral, rectal, tympanic, or core temperature > 38.5° C)
- Hypothermia (oral, rectal, tympanic, or core temperature 5 times the upper limit of normal, or AST or ALT > 3 times the upper limit of normal with an associated total bilirubin > 2 times upper limit of normal;
- Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator);
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data;
- Planned or prior participation in any other interventional drug study within 30 days.
Data sourced from ClinicalTrials.gov (NCT04493151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.