Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Colistimethate and Colistin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)

Conditions
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Infection

Intervention / Treatment
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* Drug: Colistin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: colistin pharmacokinetics<br>Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required | Drug: Colistin<br>* Colistin i.v. three times daily as long a necessary for infection treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) |  | predose, and 0.5, 1, 2, 4, 6, 8 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sings of neurotoxicity and nephrotoxicity | 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. | Expected average of follow up is about 14 days. | 
| Sings of neurotoxicity and nephrotoxicity | 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. | Expected average of follow up is about 14 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy