Pharmacokinetics of Antibiotics in Critically Ill Patients Receiving CVVHF

Osaka University

Status: Unknown

Conditions: Acute Kidney Injury; Sepsis

Treatments: Other: blood samples and filtered fluid will be collected.

Study type: Interventional

Funder types: Other

Identifiers

NCT04800952

20235

Details and patient eligibility

About

The mortality in patients with sepsis and severe acute kidney injury requiring continuous renal replacement therapy (CRRT) remains high. Antibiotic therapy is a key treatment of these patients and in recent years new antibiotics have been licensed. However, data is lacking to determine the optimal dosing regimens of these antibiotics for high (Australia and other countries) and low intensity (Japan) of CRRT.

Aim To establish the appropriate dosing regimens of newly available antibiotics during CRRT can applied globally.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (age ≥18 years or older)
• Sepsis (Sepsis-3 criteria)
• Acute kidney injury requiring CRRT (KDIGO criteria)
• Eligible for intensive care without restrictions or limitations

Exclusion criteria

• Chronic renal failure
• Obvious or suspected pregnancy
• Intracranial bleeding

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

To establish the appropriate dosing regimens of newly available antibiotics during CRRT

Other group

Description:

High dose (world standard dose) and low dose CRRT (Japan local) CRRT protocol Vascular access will be obtained by inserting a double-lumen dialysis catheter into the internal jugular or femoral veins. High dose CRRT in Australia, Blood flow through the extracorporeal circuit will be maintained at 150 ml/min. The CVVHF replacement volume will be set at 25ml/kg/hour and bicarbonate-buffered replacement fluids will be added in post-dilutional mode. Low dose CRRT in Japan, Blood flow through the extracorporeal circuit will be maintained at 80 ml/min. CVVHF replacement volume will be set at 15ml/kg/hour and bicarbonate-buffered replacement fluids will be added in the post-dilutional mode. Fluid balance, volume removal and the duration of CVVHF will be determined by the ICU physician based on the patient's individual clinical status.

Treatment:

Other: blood samples and filtered fluid will be collected.