Status:
COMPLETED
Imipenem/Cilastatin/Relebactam PK in ECMO
Lead Sponsor:
Joseph L. Kuti, PharmD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 w...
Detailed Description
This is a single center, open-label study to determine imipenem-cilastatin-relebactam pharmacokinetics in critically ill patients receiving ECMO. Eight patients with suspected suspected sepsis and who...
Eligibility Criteria
Inclusion
- 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 \< 35.0° C)
- An elevated white blood cell (WBC) count ≥ 12,000 cells/mm3
Exclusion
- If female, currently pregnant or breast feeding;
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam agent (a history of mild rash to a β-lactam followed by uneventful re-exposure is not a contraindication);
- Severe renal dysfunction defined as a creatinine clearance \< 15 mL/min (calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis;
- Hemoglobin less than 8 mg/dL at baseline;
- Use of probenecid, valproic acid, or imipenem within 3 days before study drug infusion;
- Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04493151
Start Date
January 1 2021
End Date
June 30 2023
Last Update
August 7 2024
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102