Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02081560

Enrollment

Registered

2014-03-07

Start date

2013-11-30

Completion date

2015-08-31

Last updated

2014-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

pharmacokinetics, antibiotic, Gram negative, continuous renal replacement therapy

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

Interventions

DRUGColistin

Colistin i.v. three times daily as long a necessary for infection treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Switzerland

Contacts

Primary ContactNatascia Corti, MD

natascia.corti@usz.ch044 255 20 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026