Aminoglycoside Administration in Septic Patients

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
Intensive Care Unit, University Hospiatl of Larissa
RECRUITING
Larissa
Contact Information
Primary
Kyriaki Parisi, MD
kyriakiparisi@yahoo.com
00306948176845
Backup
Vasiliki Tsolaki, PhD
vasotsolaki@yahoo.com
00306972804419
Time Frame
Start Date: 2023-06-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
Active_comparator: CRRT group
Patients receiving aminoglycosides and submitted to CRRT
No_intervention: no-CRRT group
Patients receiving aminoglycosides and no CRRT
Related Therapeutic Areas
Sponsors
Leads: University of Thessaly

This content was sourced from clinicaltrials.gov