Pharmacokinetics of Antibiotics in Critically Ill Patients Receiving CVVHF

Not Applicable

• Conditions: Acute Kidney Injury; Sepsis

• Registration Number: NCT04800952
• Lead Sponsor: Osaka University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-24
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-16
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Study Start: 2021-04
• Primary Completion: 2022-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plasma new antibiotics concentration during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.	72 hours	New drugs are Tedizolid, Daptomycin (anti-MRSA), Tazobactam/ Ceftolozane (anti-gram negative), Metronidazole (Anti-anaerobic). Plasma antibiotics concentrations will be measured at 5 time-points and prefilter and postfilter plasma and filtered-fluid antibiotics levels will be measured at 3 time-points during CVVHF.
Calculated clearances of new antibiotics during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.	72 hours	New drugs are Tedizolid, Daptomycin (anti-MRSA), Tazobactam/ Ceftolozane (anti-gram negative), Metronidazole (Anti-anaerobic). Total clearance by CVVHF: (Cltotal) = (Cpre - Cpost / Cpre) × Blood flow (ml/min), Clearance by filtration: (Clfil) = (Clfil / Cpre)× replacement volume (ml/min), Clearance by absorption of the filter: (Clab) = (Cltotal) - (Clfil) (ml/min).

Secondary Outcome Measures

Name	Time	Method
Concentration of serum creatinine	through study completion, an average of 1 year	Concentration of serum creatinine
length of stay in the hospital	up to 30 days, length of stay in the hospital will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge	length of stay in the hospital
ICU Mortality	at ICU discharge assessed up to 30 days	Mortality at ICU discharge
Hospital Mortality	at hospital discharge assessed up to 30 days	Mortality at hospital discharge