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

NCT ID: NCT01932814

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-08-31

Brief Summary

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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

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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

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Acute Kidney Injury Severe Sepsis

Keywords

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Aminoglycosides Acute kidney injury Severe sepsis Critically ill patient

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aminoglycosides

have received aminoglycosides

No interventions assigned to this group

No Aminoglycosides

did not receive aminoglycosides

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Victor Segalen Bordeaux 2

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Boyer

MD,phD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Service de Réanimation médicale, Hôpital Pellegrin

Bordeaux, Aquitaine, France

Site Status

Countries

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France

References

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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 Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

Reference Type RESULT
PMID: 15312219 (View on PubMed)

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. doi: 10.1016/s0002-9610(05)81007-4.

Reference Type RESULT
PMID: 2240380 (View on PubMed)

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: 10.1007/s40264-013-0031-0.

Reference Type RESULT
PMID: 23508544 (View on PubMed)

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, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.

Reference Type RESULT
PMID: 18158437 (View on PubMed)

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. doi: 10.1378/chest.115.2.462.

Reference Type RESULT
PMID: 10027448 (View on PubMed)

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. 2010 Aug;38(8):1651-64. doi: 10.1097/CCM.0b013e3181e96b91.

Reference Type RESULT
PMID: 20562695 (View on PubMed)

Other Identifiers

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REAMICHOC

Identifier Type: -

Identifier Source: org_study_id