Aminoglycoside Administration in Septic Patients

NCT06226441 | Recruiting

• 1 other identifier: 25479/24-05-2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; Aminoglycoside Toxicity; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (3)

• Number of total aminoglycoside doses during 8 days.

  Number of total aminoglycoside doses during the study period of 8 days

  8 days

• Cpeak aminoglycoside achievement

  Evaluation of aminoglycoside Cpeaks in the serum of patients following such a protocol

  8 days

• 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 Outcomes (10)

• 28day mortality

  28 days from day of enrollment

• Renal function

  28 days ffrom day of enrollment

• CVVHDF free days

  28 days from day of enrollment

• inflammatory marker evaluation

  8 days from day of enrollment

• ICU length of stay

  from day of enrollment up to 6 months

Study Arms (2)

CRRT group

ACTIVE COMPARATOR

Patients receiving aminoglycosides and submitted to CRRT

Procedure: Continuous Renal Replacement Therapy

no-CRRT group

NO INTERVENTION

Patients receiving aminoglycosides and no CRRT

Interventions

Continuous Renal Replacement Therapy PROCEDURE

CRRT

CRRT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Intensive Care Unit, University Hospiatl of Larissa

Larissa, Thessaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Epaminondas Zakynthinos, Prof

  University Hospital of Larissa, Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyriaki Parisi, MD

CONTACT

00306948176845; kyriakiparisi@yahoo.com

Vasiliki Tsolaki, PhD

CONTACT

00306972804419; vasotsolaki@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic scholar

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 26, 2024
• Study Start: June 2, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)