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

NCT01932814 | Completed

• 1 other identifier: REAMICHOC
• Study Type: observational
• Target: 317
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Kidney Injury; Severe Sepsis

Keywords

Aminoglycosides; Acute kidney injury; Severe sepsis; Critically ill patient

Outcome Measures

Primary Outcomes (1)

• The incidence of acute renal injury associated with treatment with aminoglycoside in critically ill septic patients

  between day 4 and day 15

Secondary Outcomes (1)

• Risk factors of acute kidney injury

  between day 1and day 3

Other Outcomes (2)

• Risk factors for ICU mortality

  between day 4 and day 15

• Pharmacokinetics parameters of aminoglycosides

  between day 1 to day 6

Study Arms (2)

Aminoglycosides

have received aminoglycosides

No Aminoglycosides

did not receive aminoglycosides

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill septic patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Victor Segalen Bordeaux 2: lead

Study Sites (1)

Service de Réanimation médicale, Hôpital Pellegrin

Bordeaux, Aquitaine, 33000, France

Location

Related 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 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.

  PMID: 15312219 RESULT

• 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.

  PMID: 2240380 RESULT

• 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.

  PMID: 23508544 RESULT

• 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.

  PMID: 18158437 RESULT

• 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.

  PMID: 10027448 RESULT

• 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.

  PMID: 20562695 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,phD

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

FR (1)