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Case Study A

Observational study measuring clearance of antibiotics during dialysis

The study      

Dr A wants to study how quickly antibiotics used to treat septic [1] patients in Intensive Care Units (ICUs) are removed by dialysis. It is already known that most antibiotics are removed by dialysis to some extent, but the rate can vary. Consumers with severe sepsis often require dialysis therapy due to acute kidney injury. A special form of dialysis is used for these consumers in the ICU, but currently there is no information available regarding the rate at which that form of dialysis removes the antibiotics used to treat sepsis. If antibiotics are cleared by dialysis at a faster rate than expected, the sepsis could be undertreated.

Dr A proposes a study involving acutely unwell septic patients in the ICU, who are unlikely to be able to provide informed consent owing to the impact of the sepsis. Dr A will not amend the treatment provided to the study participants - they would be provided with antibiotics and dialysis in the same way as they would outside of the study. However, Dr A would enrol the participants in his research and measure the changes in antibiotic concentrations during the participants' dialysis sessions. Changes would be measured by a number of tests, including urine and blood tests that would not otherwise be performed.

Information from the study would not affect the clinical management of the participants, and they would not benefit from the research. However, Dr A believes the data gathered may lead to more accurate dosing of antibiotics for other septic patients in ICUs in the future.   

[1] Sepsis is a serious illness. It happens when the person's body has an overwhelming immune response to an infection.

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