Sepsis Clinical Trial
— AMASEPOfficial title:
Aminoglycoside Administration in Septic Patients
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Intensive Care Unit, University Hospiatl of Larissa | Larissa | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of total aminoglycoside doses during 8 days. | Number of total aminoglycoside doses during the study period of 8 days | 8 days | |
Primary | Cpeak aminoglycoside achievement | Evaluation of aminoglycoside Cpeaks in the serum of patients following such a protocol | 8 days | |
Primary | Clinical effectiveness through SOFA score evaluation. | Evaluate clinical effectiveness of the protocol based on the Sequential Organ Failure Assessment (SOFA) score during days 1, 4, 8, 11 of their monitoring. Score range 0-24, with higher values denoting worse clinical condition. | 11 days | |
Secondary | 28day mortality | 28day mortality | 28 days from day of enrollment | |
Secondary | Renal function | Urea (mg/dl) | 28 days ffrom day of enrollment | |
Secondary | CVVHDF free days | Hospital days without CVVHDF (within 28 days from the start of treatment) | 28 days from day of enrollment | |
Secondary | inflammatory marker evaluation | WBC, x1000/µL | 8 days from day of enrollment | |
Secondary | ICU length of stay | ICU length of stay | from day of enrollment up to 6 months | |
Secondary | ICU mortality | ICU mortality | from day of enrollment up to 6 months | |
Secondary | Renal Function | Creatinine (mg/dl) | 28 days ffrom day of enrollment | |
Secondary | Renal Function | GFR, ml/min/1.73 m2 | 28 days ffrom day of enrollment | |
Secondary | Inflammatory Marker Evaluation | CRP, mg/dl | 8 days from day of enrollment | |
Secondary | Inflammatory Marker Evaluation | Procalcitonin, µg/L | 8 days from day of enrollment |
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