Pharmacokinetics of Antibiotics in Critically Ill Patients Receiving CVVHF

Sepsis Clinical Trial

Official title:

Pharmacokinetics of New Licensed Antibiotics in Critically Ill Patients Receiving Continuous Venovenous Haemofiltration: An International Collaborative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04800952
• Other study ID #: 20235
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: April 2023

Study information

• Verified date: March 2021
• Source: Osaka University
• Contact: Naoya Iguchi, MD, PhD
• Phone: +81 6 6879 3133
• Email: iguchi[@]hp-icu.med.osaka-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2023
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis

Intervention

Other:
• blood samples and filtered fluid will be collected.
Arterial blood samples will be collected just before the commencement of continuous venovenous haemofiltration (CVVHF) and 1 h after the termination of CVVHF. Prefilter and post-filter venous blood samples and filtered fluid will be collected 1 and 3 h after the commencement of CVVHF and at the end of CVVHF.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osaka University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma new antibiotics concentration during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.	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.	72 hours
Primary	Calculated clearances of new antibiotics during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.	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).	72 hours
Secondary	Concentration of serum creatinine	Concentration of serum creatinine	through study completion, an average of 1 year
Secondary	length of stay in the hospital	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
Secondary	ICU Mortality	Mortality at ICU discharge	at ICU discharge assessed up to 30 days
Secondary	Hospital Mortality	Mortality at hospital discharge	at hospital discharge assessed up to 30 days