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

Sponsor

Université Victor Segalen Bordeaux 2 (Other)

Overall Status

Completed

CT.gov ID

NCT01932814

Collaborator

(none)

317

Enrollment

Location

Duration (Months)

28.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Severe Sepsis

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 Design

Study Type:

Observational

Actual Enrollment :

317 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Aminoglycosides have received aminoglycosides
No Aminoglycosides did not receive aminoglycosides

Outcome Measures

Primary Outcome Measures

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

Risk factors of acute kidney injury [between day 1and day 3]

Other Outcome Measures

Risk factors for ICU mortality [between day 4 and day 15]
Pharmacokinetics parameters of aminoglycosides [between day 1 to day 6]
daily dose, peak serum concentration, through level serum concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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