PK of Meropenem in Patients on Plasma Exchange
Study Details
Study Description
Brief Summary
Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Meropenem: Patients who underwent TPE (Phase 1) In phase 1, each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first therapeutic plasma exchange (TPE) and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration. |
Drug: meropenem
each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
|
| Meropenem: after TPE (Phase 2) was similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE |
Drug: meropenem
each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
|
Outcome Measures
Primary Outcome Measures
- The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration [0-8 hours after the drug administration]
Secondary Outcome Measures
- Maximum plasma concentration [Cmax] [0-8 hours after the drug administration]
- Minimum plasma concentration [Cmin] [0-8 hours after the drug administration]
- Area under the plasma concentration versus time curve [AUC] [0-8 hours after the drug administration]
- half-life [t1/2] [0-8 hours after the drug administration]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age≥ 18 years
-
no shock
-
hemoglobin ≥ 7 g/dl
Exclusion Criteria:
-
pregnancy or breast-feeding female
-
history of hypersensitivity to carbapenems
-
renal replacement therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine, Prince of Songkla University, Thailand | Hat Yai | Songkla | Thailand | 90110 |
Sponsors and Collaborators
- Prince of Songkla University
Investigators
- Principal Investigator: Sutep Jaruratanasirikul, M.D., Faculty of Medicine, Prince of Songkla University, Thailand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- meropenem-plasma exchange