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Completed

NCT Number: NCT02556190

Colistin Pharmacokinetics in Critically Ill Patients During Extended Dialysis

The emergence of multidrug-resistant bacteria has recently renewed interest in colistin. Data on dosing in critically ill patients undergoing extended dialysis are missing. The aim of this study is to determine the pharmacokinetics of colistin during extended dialysis in critically ill patients and to provide dosing guidelines for this drug.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

About this study

Due to the lack of new antibiotics for the treatment of critically ill patients with multidrug-resistant bacteria, interest in "old" antibiotics like colistin re-emerged. Lastly, colistin is administered more frequently especially in cases of infections due to Pseudomonas aeruginosa, Klebsiella pneumoniae or Acinetobacter baumanii in intensive care units (ICUs) around the world. However, dosing of colistin in critically ill patients undergoing renal replacement therapy is based on scarce data. The aim of this study is to evaluate single and multiple-dose pharmacokinetics of both colistin and its inactive prodrug colistin-methanesulfonate (CMS) in critically ill patients with acute kidney injury (AKI) undergoing extended daily dialysis (EDD).

The investigators perform a prospective clinical pharmacokinetic single- and multiple-dose study in the medical and surgical ICUs of the Hannover Medical School. ICU patients with anuric AKI being treated with EDD and receiving i.v. colistin are studied on day 1 and (if possible) on day 5-9 of treatment. A loading dose of 6 Mio IU colistin ís administered 8 hours prior to the EDD session followed by 3 Mio IU every 8 hours. Colistin Plasma concentration levels as well as dialyzer clearance rates are measured at different time points.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for colistin therapy
  • Acute kidney injury AKIN III with need for renal replacement therapy

Exclusion criteria

  • participation in other studies
  • pregnancy
  • known colistin allergy or other contraindications for colistin therapy

Treatment and study plan

Primary outcomes

  1. Colistin elimination during extended dialysis

    Time frame: Participants will be followed for 10 days. Colistin elimination measured by the total drug amount in the collected spent dialysate

    Colistin elimination during extended dialysis is measured on day 1 and day 9 after colistin therapy was started. Colistin elimination is measured by the total eliminated drug amount in the total spent dialysate

Secondary outcomes

  1. Colistin peak concentration during extended daily dialysis C(max)

    Time frame: Participants will be followed for 10 days. Colistin concentration is measured at different time points after drug infusion: 0, 0.5, 1, 1.5, 2, 4, 6, 8) on day 1 and day 9 after therapy initiation

  2. Colistin trough Level during extended daily dialysis C(max)

    Time frame: Participants will be followed for 10 days. Colistin concentration is measured at different time points after drug infusion: 0, 0.5, 1, 1.5, 2, 4, 6, 8) on day 1 and day 9 after therapy initiation

  3. Colistin dialyzer clearance during extended dialysis

    Time frame: Participants will be followed for 10 days. Dialyzer clearance is calculated after 30 and 180 minutes of extended dialysis on day 1 and day 9 after therapy initiation

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Colistin Pharmacokinetics in Critically Ill Patients With Acute Kidney Injury AKIN III During Extended Dialysis Using the GENIUS Dialysis System

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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