PK of Meropenem in Patients on Plasma Exchange

Prince of Songkla University

Status: Unknown

Conditions: Autoimmune Diseases

Treatments: Drug: meropenem

Study type: Observational

Funder types: Other

Identifiers

NCT05042271

meropenem-plasma exchange

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Meropenem: Patients who underwent TPE (Phase 1)

Description:

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.

Treatment:

Drug: meropenem

Meropenem: after TPE (Phase 2)

Description:

was similar to phase 1 except that the meropenem administration and PK studies were conducted \>6 hours apart from the next TPE

Treatment:

Drug: meropenem