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

Acute Kidney Injury Clinical Trial

— REAMICHOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932814
• Other study ID #: REAMICHOC
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: August 27, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Université Victor Segalen Bordeaux 2
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Severe Sepsis

Locations

Country	Name	City	State
France	Service de Réanimation médicale, Hôpital Pellegrin	Bordeaux	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Université Victor Segalen Bordeaux 2

Country where clinical trial is conducted

France, 

References & Publications (6)

Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Confere — View Citation

Boucher BA, Coffey BC, Kuhl DA, Tolley EA, Fabian TC. Algorithm for assessing renal dysfunction risk in critically ill trauma patients receiving aminoglycosides. Am J Surg. 1990 Nov;160(5):473-80. — View Citation

Boyer A, Gruson D, Bouchet S, Clouzeau B, Hoang-Nam B, Vargas F, Gilles H, Molimard M, Rogues AM, Moore N. Aminoglycosides in septic shock: an overview, with specific consideration given to their nephrotoxic risk. Drug Saf. 2013 Apr;36(4):217-30. doi: 10. — View Citation

Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimm — View Citation

Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74. — View Citation

Kumar A, Safdar N, Kethireddy S, Chateau D. A survival benefit of combination antibiotic therapy for serious infections associated with sepsis and septic shock is contingent only on the risk of death: a meta-analytic/meta-regression study. Crit Care Med. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Risk factors for ICU mortality		between day 4 and day 15	No
Other	Pharmacokinetics parameters of aminoglycosides	daily dose, peak serum concentration, through level serum concentration	between day 1 to day 6	No
Primary	The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients		between day 4 and day 15	No
Secondary	Risk factors of acute kidney injury		between day 1and day 3	No