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Impact of haemodiafiltration on the pharmacokinetics of potent antibiotics.

Impact of haemodiafiltration on the pharmacokinetics of potent antibiotics, Meropenem and Tazociin.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000078459
Acronym
None
Enrollment
6
Registered
2016-01-25
Start date
2016-05-31
Completion date
2016-10-10
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate how quickly two potent anitbiotics used to treat septic patients in the ICU are removed by haemodiafiltration (HDF). Septic patients often have acute kidney injury and require HDF support to maintain kidney function. We do not know how well antibiotics are removed by HDF and therefore do not have appropriate dosing guidelines to ensure adequate therapeutic concentrations of the antibiotic is maintained. This study will measure the changes in antibiotic concentrations over a HDF session. The results will enable us to more accurately recommend the correct dose and timing for the dose for septic patients with acute kidney injury.

Interventions

The pharmacokinetic study relates to a single HDF session, where the antibiotic (meropenem or tazocin) will be administered intravenously at 30 minutes prior to the start of the dialysis session. Basline bloods are taken. The anitbiotic is administered followed by a 15 and 30 minute sample. The dialysis session is then started and samples are then taken (15 min, 30 min, 60 min, 2 hours and 4 hours) to measure antibiotic concentrations over time during the 4 hour dialysis session followed by a p

The pharmacokinetic study relates to a single HDF session, where the antibiotic (meropenem or tazocin) will be administered intravenously at 30 minutes prior to the start of the dialysis session. Basline bloods are taken. The anitbiotic is administered followed by a 15 and 30 minute sample. The dialysis session is then started and samples are then taken (15 min, 30 min, 60 min, 2 hours and 4 hours) to measure antibiotic concentrations over time during the 4 hour dialysis session followed by a post dialysis sample 1 hour after completion.. Dose of Meropenem is 1gm IV (session 1) Dose of tazocin 4.5gms IV (session 2). Each participant will undergo 2 pharmacokinetic clearance studies on HDF. One for meropenem pharmacokinetics and one for Tazocin pharmacokinetics These studies will be separated by at least a week.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Stable haemodialysis patients aged from 18 - 75 years. able to give informed consent.

Exclusion criteria

Unable to give consent. Known penicillin allergy or previous allergy to meropenem or tazocin. An intercurrent infection requiring antibiotic therapy.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 1, 2026