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| ID | Type | Description | Link |
|---|---|---|---|
| 213DR11032 | Other Identifier | Swissmedic |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colistin pharmacokinetics | Other | Intravenous colistin 9 million units loading dose and 3 million units q8h maintenance dose as long as treatment of infection is required |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistin | Drug | Colistin i.v. three times daily as long a necessary for infection treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) | predose, and 0.5, 1, 2, 4, 6, 8 hours after administration |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natascia Corti, MD | Contact | 044 255 20 78 | natascia.corti@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Natascia Corti, MD | University Hospital Zurich, Dept. of Pharmacology and Toxicology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Zurich, Dept. of Pharmacology and Toxicology | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30478168 | Derived | Leuppi-Taegtmeyer AB, Decosterd L, Osthoff M, Mueller NJ, Buclin T, Corti N. Multicenter Population Pharmacokinetic Study of Colistimethate Sodium and Colistin Dosed as in Normal Renal Function in Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01957-18. doi: 10.1128/AAC.01957-18. Print 2019 Feb. |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003091 | Colistin |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 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. |
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |