Using aminoglycosides to treat sepsis in patients with kidney issues
Aminoglycoside Administration in Septic Patients
This study is testing if a specific type of antibiotic can safely help patients with kidney problems who have sepsis or septic shock.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Larissa, Thessaly) |
| Trial ID | NCT06226441 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of aminoglycosides, a class of antibiotics, in patients suffering from sepsis or septic shock, particularly those with impaired kidney function. The study aims to address the challenges of administering these antibiotics effectively while minimizing nephrotoxicity, which is a common concern in critically ill patients. By focusing on the pharmacokinetics of aminoglycosides in this population, the trial seeks to optimize dosing strategies to improve patient outcomes. Participants will receive continuous renal replacement therapy to manage their renal function during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with sepsis or septic shock and having a GFR of less than 40 ml/min.
Not a fit: Patients with known allergies to aminoglycosides or infections caused by strains resistant to these antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of aminoglycosides in treating sepsis while reducing the risk of kidney damage.
How similar studies have performed: Other studies have shown promise in using aminoglycosides for treating multidrug-resistant infections, but this specific approach in septic patients with renal impairment is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 years * diagnosis of sepsis or septic shock based on established criteria (Sepsis-3) 29 * patients with GFR \<40 ml/min * microbiemia from a Gram-negative microorganism and for which the attending physician decides to receive an aminoglycoside or sepsis/septic shock for which it is decided to administer it * signed consent of the patients' next of kin Exclusion Criteria: * absence of consent * known allergic reaction to aminoglycosides * infection from strains resistant to aminoglycosides. As long as the patient has received an aminoglycoside (empirical regimen) and the antibiogram follows it, the treatment can be modified based on the judgment of the attending physician, but the patient's data for the time he received the treatment under consideration are recorded and evaluated * unattainable placement of a central venous line for renal replacement therapy
Where this trial is running
Larissa, Thessaly
- Intensive Care Unit, University Hospiatl of Larissa — Larissa, Thessaly, Greece (Recruiting)
Study contacts
- Principal investigator: Epaminondas Zakynthinos, Prof — University Hospital of Larissa, Intensive Care Unit
- Study coordinator: Kyriaki Parisi, MD
- Email: kyriakiparisi@yahoo.com
- Phone: 00306948176845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.