Colistin Pharmacokinetics in Critically Ill Patients During Extended Dialysis

NCT02556190 | Completed

• 1 other identifier: COL-6446-2013
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection Due to Resistant Bacteria; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Colistin elimination during extended dialysis

  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

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

Secondary Outcomes (3)

• Colistin peak concentration during extended daily dialysis C(max)

  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

• Colistin trough Level during extended daily dialysis C(max)

  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

• Colistin dialyzer clearance during extended dialysis

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients in a tertiary hospital with acute kidney injury AKIN III with need for renal replacement and colistin therapy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• Schmidt JJ, Strunk AK, David S, Bode-Boger SM, Martens-Lobenhoffer J, Knitsch W, Scherneck S, Welte T, Kielstein JT. Single- and multiple-dose pharmacokinetics and total removal of colistin in critically ill patients with acute kidney injury undergoing prolonged intermittent renal replacement therapy. J Antimicrob Chemother. 2019 Apr 1;74(4):997-1002. doi: 10.1093/jac/dky511.

  PMID: 30624668 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* blood samples * dialysate samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jan T Kielstein, Prof

  Hannover Medical School, Dep. of Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 22, 2015
• Study Start: June 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 24, 2016

Record last verified: 2016-08

Locations

DE (1)