Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06226441

Aminoglycoside Administration in Septic Patients with Impaired Renal Function Using Continuous Renal Replacement Therapy to Optimize Dosing and Minimize Toxicity

Led by University of Thessaly · Updated on 2024-01-26

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sepsis and septic shock are serious conditions that often lead to death or severe illness in intensive care units (ICUs). This research focuses on infections caused by multidrug-resistant gram-negative bacteria, which are common in these patients. Aminoglycosides are antibiotics known to be effective against these bacteria, but their use can be limited by kidney-related side effects, especially in patients with existing kidney problems. The study aims to see if using a special blood filtering technique can help remove the antibiotic after it reaches a strong level in the blood, reducing potential harm while maintaining its effectiveness. The study compares three groups of ICU patients who have sepsis or septic shock and impaired kidney function. One group receives continuous renal replacement therapy (CRRT) alongside aminoglycoside antibiotics, another starts antibiotics first and later begins CRRT if needed, and the third group receives antibiotics without CRRT. Aminoglycosides like amikacin, gentamicin, and tobramycin are given in specific doses, and CRRT is used to clear the drug from the bloodstream to allow safer and potentially more frequent dosing. CRRT is applied using filters and anticoagulants, with treatment schedules varying among the groups. Participants will be monitored closely for drug levels in their blood, kidney function, infection markers, and overall health using scores like SOFA over several days. Blood cultures and kidney clearance tests are done before and during treatment. The study tracks several outcomes including how many doses of antibiotic can be given, drug concentration achievement, clinical response during 11 days, and longer-term effects such as mortality, kidney health, inflammation markers, ICU stay length, and survival up to six months.

CONDITIONS

Brief Title

Aminoglycoside Administration in Septic Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of sepsis or septic shock based on established criteria (Sepsis-3)
  • Patients with glomerular filtration rate (GFR) below 40 ml/min
  • Bloodstream infection from a gram-negative microorganism requiring aminoglycoside treatment or sepsis/septic shock where aminoglycoside administration is decided
  • Signed consent from the patient or first-degree relative
Not Eligible

You will not qualify if you...

  • Absence of consent
  • Known allergic reaction to aminoglycosides
  • Infection with strains resistant to aminoglycosides unless modified treatment data are recorded
  • Inability to place a central venous line for continuous venovenous hemodialysis (CVVHDF)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 8 days

Participants receive aminoglycoside antibiotics and may undergo continuous renal replacement therapy (CRRT) to optimize dosing and minimize toxicity. Treatment includes monitoring of drug levels and clinical effectiveness.

Daily visits during treatment period

Follow-up

Duration - Up to 6 months

Participants are monitored for clinical outcomes including SOFA score, renal function, inflammatory markers, and mortality up to 28 days after enrollment. ICU length of stay and mortality are also tracked up to 6 months.

Periodic visits or assessments during ICU stay and up to 6 months

Trial Site Locations

Total: 1 location

1

Intensive Care Unit, University Hospiatl of Larissa

Larissa, Thessaly, Greece, 41110

Actively Recruiting

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Research Team

K

Kyriaki Parisi, MD

V

Vasiliki Tsolaki, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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