Colistin Pharmacokinetics in Continuous Renal Replacement Therapy

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT02081560

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Colistin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Other: colistin pharmacokinetics

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

Drug: Colistin

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

Outcome Measures

Primary Outcome Measures

Area under the curve (AUC) [predose, and 0.5, 1, 2, 4, 6, 8 hours after administration]

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Zurich, Dept. of Pharmacology and Toxicology	Zurich	ZH	Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator: Natascia Corti, MD, University Hospital Zurich, Dept. of Pharmacology and Toxicology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT02081560

Other Study ID Numbers:

COLPKZH11
213DR11032

First Posted:

Mar 7, 2014

Last Update Posted:

Mar 7, 2014

Last Verified:

Mar 1, 2014

Keywords provided by University of Zurich

pharmacokinetics

antibiotic

Gram negative

continuous renal replacement therapy

Additional relevant MeSH terms:

Colistin

Study Results

No Results Posted as of Mar 7, 2014