10052341EIT KIC 2022ClosedEU-FundedHorizon Europe GuaranteeThe IMPACCT study will investigate whether it is possible to use a new diagnostic test to identify and classify patients with sepsis who are at higher risk of poor outcomes and developing new infections. The IMPACCT study is being sponsored and managed by Imperial College London in the UK and the Chief Investigator is Professor Anthony Gordon. Sepsis is when severe infection leads to organ failure. It is a major global healthcare problem. Recent studies suggest as many as 49 million cases of sepsis worldwide each year leading to 11 million deaths. As sepsis care has improved more patients now recover from the early phases of sepsis but repeat occurrences are a major problem. Patients with sepsis often experience weakening of their immune systems known as immune suppression. This is now recognised as an important feature in a large proportion of patients who have sepsis and it leads to poor outcomes for these patients. At present there is no clinical test to assess the immune function of patients who have sepsis. IMPACCT will evaluate if a rapid RNA-based diagnostic test that produces an Immune Profiling Panel (IPP) can identify patients with sepsis who are immunosuppressed and at higher risk of poor outcomes. It is an observational study with no intervention or novel treatment introduced and no change to patients’ standard care and treatment when taking part. Over a 2-year period, the study will recruit 600 patients in hospitals in the UK, France, and Sweden. Participants will be adult patients in intensive care who are being, or have been, treated for suspected sepsis and are receiving, or have received, organ support. The patients will have been admitted to an ICU for over 48hours and less than 120 hours (5 days) and are expected to require ongoing care in an environment capable of providing organ support for at least one more calendar day. The study research team will collect data on the patient’s medical condition throughout their treatment in hospital and will conduct a clinical diagnostic test on participants’ blood samples. Blood samples will be taken from patients at 3 time points during the study and will be taken from indwelling lines where present. Test results will not be shared with the research team or influence patients’ care. Patients will be contacted 90 days after inclusion to complete a diary regarding their wellbeing and any new infections.