Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06226441

Aminoglycoside Administration in Septic Patients

Led by University of Thessaly · Updated on 2024-01-26

50

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sepsis is one of the main causes of mortality and morbidity in an ICU setting, while the responsible microorganisms most frequently isolated are multidrug-resistant gram-negative bacteria. Aminoglycoseides (AG) seem to be particularly effective in dealing with these microbes, however their potential toxicity, especially nephrotoxicity, often makes them an unsuitable treatment option. This becomes particularly evident in patients with already impaired renal function, a common occurrence in septic patients requiring ICU treatment. AG are bacteriocidal antibiotics the efficiency of which depends on the maximum concentration in patients' serum (Cpeak). Pathophysiological changes in critically ill patients, result in significant distribution of the drug extravascullary resulting in a decreased concentration of the biologically active component. On the other hand, impaired renal clearance results in high serum drug levels (C trough) making the desired once-daily administration not always achieved. The purpose of this study is to test the hypothesis of successful clearance of AG after achieving satisfactory serum levels and therefore their maximum effect minimizing potential toxicity, by using continuous veno-venous haemodiafiltration in patients with sepsis or septic shock and impaired renal function. This way, the aforementioned antibiotics could become a more frequent and potentially earlier choice for physicians in the treatment of sepsis and septic shock patients from multidrug-resistant microbes.

CONDITIONS

Official Title

Aminoglycoside Administration in Septic Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosis of sepsis or septic shock based on established criteria (Sepsis-3)
  • Glomerular filtration rate (GFR) less than 40 ml/min
  • Bloodstream infection from a Gram-negative microorganism with decision to receive aminoglycoside treatment
  • Signed consent from the patient or first-degree relative
Not Eligible

You will not qualify if you...

  • No consent provided
  • Known allergic reaction to aminoglycosides
  • Infection caused by aminoglycoside-resistant strains
  • Unable to place a central venous line suitable for continuous venovenous hemodialysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Intensive Care Unit, University Hospiatl of Larissa

Larissa, Thessaly, Greece, 41110

Actively Recruiting

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Research Team

K

Kyriaki Parisi, MD

CONTACT

V

Vasiliki Tsolaki, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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