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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01932814
• Date of registration: 27/08/2013
• Prospective Registration: No
• Primary sponsor: Université Victor Segalen Bordeaux 2
• Public title: Acute Kidney Injury in Septic Critically Ill Patients : Are Aminoglycosides Really Harmful? REAMICHOC
• Scientific title: Retrospective Analysis of Aminoglycoside-associated Acute Renal Injury in Septic Critically Ill Patients
• Date of first enrolment: September 2012
• Target sample size: 317
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01932814
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Kidney Injury

Severe Sepsis

Primary Outcome(s)

The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients [Time Frame: between day 4 and day 15]

Secondary Outcome(s)

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

Secondary ID(s)

REAMICHOC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors