Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Intensive Care Unit, University Hospiatl of Larissa
Larissa, Thessaly, Greece, 41110
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here