Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

Phase 4

• Conditions: Infection
• Interventions: Drug: Colistin

• Registration Number: NCT02081560
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-27
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Study First Posted: 2014-03-07
• Last Update Posted: 2014-03-07
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
colistin pharmacokinetics	Colistin	Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC)	predose, and 0.5, 1, 2, 4, 6, 8 hours after administration

Secondary Outcome Measures

Name	Time	Method
Sings of neurotoxicity and nephrotoxicity	Expected average of follow up is about 14 days.	Clinical investigation daily by assessing clinical signs and questioning the patient regarding sign of neuropathy and difficulty breathing in non intubated patients. Questioning the treating physician in intubated patients regarding objective signs of increased ventilation support. The patients will be followed for the duration of colistin administration at the dose studied.

Trial Locations

Locations (1)

University Hospital of Zurich, Dept. of Pharmacology and Toxicology; 🇨🇭 Zurich, ZH, Switzerland