Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

University of Zurich (UZH)

Status and phase: Unknown; Phase 4

Conditions: Infection

Treatments: Drug: Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT02081560

COLPKZH11

213DR11032 (Other Identifier)

Details and patient eligibility

About

The blood concentration of the antibiotic colistin is determined in patients in whom kidney function is reduced such that a renal replacement therapy is needed.

Hypothesis:no dose reduction is needed in patients undergoing continuous renal replacement therapy over 24h because colistin is sufficiently removed by this procedure.

Full description

After administration of intravenous Colistin multiple blood samples are drawn over one dosing interval on day 1, 3, and 5 of treatment.

Patients are monitored for signs of neuro- and nephrotoxicity

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female aged 18 years or older
• hospitalised on the ICU
• gram-negative infection requiring antibiotic therapy with intravenous colistin as part of their routine medical care
• clinical necessity for continuous venovenous renal replacement therapy

Exclusion criteria

• History of hypersensitivity to colistin or to other polymyxins
• Personal or family history of Myasthenia Gravis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

colistin pharmacokinetics

Other group

Description:

Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required

Treatment:

Drug: Colistin