Acute Kidney Injury, Sepsis
Conditions
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.
Interventions
OTHERblood 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.
Sponsors
Osaka University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactNaoya Iguchi, MD, PhD
Outcome results
None listed