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

Completed

• Conditions: Severe Sepsis; Acute Kidney Injury

• Registration Number: NCT01932814
• Lead Sponsor: Université Victor Segalen Bordeaux 2

Brief 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.

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Last Update Submitted: 2013-08-27
• Study First Posted: 2013-08-30
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Age 18 and older
• Admission to ICU with severe sepsis
• Hospitalized and without acute kidney injury or with kidney function improved on the third day were included
• Information provided to the patient or proxy

Exclusion Criteria

• Renal replacement therapy before day 3
• Patients with renal insufficiency J1 (Day 1 creatinine clearance <56.25 ml/mn/1, 73m2) but severely altered between Day 1 and Day 3 (creatinine clearance Day 1/ Day 3> 1 + Day 3 creatinine clearance <37.5 ml/mn/1, 73m2 ) without renal replacement therapy still necessary before J3
• Prolonged aminoglycosides therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients	between day 4 and day 15

Secondary Outcome Measures

Name	Time	Method
Risk factors of acute kidney injury	between day 1and day 3

Trial Locations

Locations (1)

Service de Réanimation médicale, Hôpital Pellegrin; 🇫🇷 Bordeaux, Aquitaine, France