NCT06226441 Aminoglycoside Administration in Septic Patients
| NCT ID | NCT06226441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Thessaly |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-06-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-06-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Epaminondas Zakynthinos, Prof
PRINCIPAL INVESTIGATOR
University Hospital of Larissa, Intensive Care Unit
Frequently Asked Questions
Who can join the NCT06226441 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226441 currently recruiting?
Yes, NCT06226441 is actively recruiting participants. Contact the research team at kyriakiparisi@yahoo.com for enrollment information.
Where is the NCT06226441 trial being conducted?
This trial is being conducted at Larissa, Greece.
Who is sponsoring the NCT06226441 clinical trial?
NCT06226441 is sponsored by University of Thessaly. The principal investigator is Epaminondas Zakynthinos, Prof at University Hospital of Larissa, Intensive Care Unit. The trial plans to enroll 50 participants.