NCT01932814

Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful?

Retrospective Analysis of Aminoglycoside-associated Acute Renal Injury in Septic Critically Ill Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 317 (actual)
• Sponsor: Université Victor Segalen Bordeaux 2 · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury

Detailed description

Severe sepsis and septic shock despite recent advances in surviving sepsis campaign remain encumbered by a high mortality rate close to 30%. One cornerstone of the management of these patients remains the early and appropriate antibiotic administration, , which must be also active at the site of infection. Aminoglycosides are often administered in combination with beta lactams in this context . According to the progress in pharmacokinetic management achieved over the past decade, their safety and efficiency tended to increase but many uncertainties remain. The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury. Study design: This is an open retrospective monocentric cohort study including septic critically ill patients from november 2008 to january 2010. To determine the incidence and the specific risk of nephrotoxicity of aminoglycosides, only hospitalized patients without initial acute kidney injury or with rapidly improving kidney function during the three first days will be included.Primary outcome will be the occurrence of acute kidney injury assessed with the RIFLE classification (Risk, Injury, Failure, Loss, and End-stage kidney disease) from day 4 to day 15. Patients receiving aminoglycosides will be compared with a control group, i.e. not receiving them. We estimated hazard ratios (HR) and 95% confidence intervals (CI) with adjusted and propensity score (PS)-matched Cox-proportional hazards models.

Conditions

• Acute Kidney Injury
• Severe Sepsis

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-08-30
• Last updated: 2013-08-30

Locations

1 site across 1 country: France