Validation of a colistin plasma concentration breakpoint as a predictor of nephrotoxicity in patients treated with colistin methanesulfonate

Int J Antimicrob Agents. 2016 Dec;48(6):725-727. doi: 10.1016/j.ijantimicag.2016.08.020. Epub 2016 Oct 7.

Abstract

Nephrotoxicity limits the effective use of colistin for the treatment of multidrug-resistant Gram-negative bacteria (MDR-GNB) infections. We previously defined a steady-state colistin plasma concentration (Css) of 2.42 mg/L that predicted nephrotoxicity at end of treatment (EOT). The objective of this study was to validate this breakpoint in a prospective cohort. This was a multicentre, prospective, observational study conducted at three hospitals with a cohort of patients treated for MDR-GNB infection with colistin methanesulfonate from September 2011 until January 2015. Nephrotoxicity was evaluated at Day 7 and at EOT using the RIFLE criteria. Css values were measured and analysed using HPLC. Taking the previously defined breakpoint for colistin concentration as a criterion, patients were divided into two groups (Css, ≤2.42 mg/L vs. >2.42 mg/L). Sixty-four patients were included. Seven patients (10.9%) had a Css > 2.42 mg/L and were compared with the remaining patients. Bivariate analysis showed that patients with a Css > 2.42 mg/L were older and had a significantly higher incidence of nephrotoxicity at Day 7 and EOT. Although not statistically significant, nephrotoxicity occurred earlier in these patients (6.2 days vs. 9.2 days in patients with lower Css; P = 0.091). Multivariate analysis of nephrotoxicity showed that Css > 2.42 mg/L was the only predictive factor. Nephrotoxicity was more frequent and occurred earlier in patients with colistin plasma concentrations higher than the previously defined breakpoint (2.42 mg/L). Colistin therapeutic drug monitoring should be routinely considered to avoid reaching this toxicity threshold and potential clinical consequences.

Keywords: Colistin; Nephrotoxicity; Plasma concentration; Risk factors; Therapeutic drug monitoring.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Acute Kidney Injury*
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / analysis*
  • Chromatography, High Pressure Liquid
  • Colistin / administration & dosage
  • Colistin / adverse effects
  • Colistin / analogs & derivatives*
  • Colistin / analysis
  • Drug Monitoring
  • Female
  • Gram-Negative Bacterial Infections / drug therapy
  • Hospitals
  • Humans
  • Male
  • Middle Aged
  • Plasma / chemistry*
  • Prospective Studies
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • colistinmethanesulfonic acid
  • Colistin