Impacct logoIMPACCT Study (Immune profiling of ICU patients to address chronic critical illness and ensure healthy ageing)
IRAS number: 286417JRCO/Sponsor’s protocol number: 20SM6207

Contact details

Chief Investigator - Prof Anthony Gordon

Dr David Antcliffe

Clinical Trial Manager - Mr Richard Cleaver

Lab/office contact number: 07999 044627 

What we do

The IMPACCT study will investigate whether it is possible, through the use of a diagnostic test, to identify and stratify patients with sepsis who are at higher risk of poor outcomes and developing new infections.  IMPACCT is an observational study with no intervention or novel treatment introduced and no change to patients’ standard care and treatment when taking part.  A clinical diagnostic test will be conducted on participants’ blood samples and the study team will collect and analyse data on the patient’s medical condition throughout their treatment in hospital and after they have been discharged. Participants will be adult patients in intensive care who are being, or have been, treated for suspected sepsis.  Over a 2-year period the study will recruit 600 patients in hospitals in the UK, France and Sweden.  
The test performed on the blood samples is a rapid RNA-based diagnostic test that produces an Immune Profiling Panel (IPP).  The IPP can then be used to categorise and stratify participants.  Blood samples will be taken from patients at 3 timepoints 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.   
Several outcomes will be collected and assessed for the participants, within hospital and following discharge.  As well as recording data throughout the participants’ care in ICU and hospital, the study team will also contact them 90 days after their inclusion in the study to complete a diary regarding their wellbeing and any new infections.  At the end of the study the analysis will examine any association between the outcomes and the stratified groups determined by the IPP. 


Why it is important

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.  


How it can benefit patients

Future patients could benefit from the findings of the study as a result of improvements to clinical care and potentially tailored personal treatments. At present there is no clinical test to assess the immune function of patients who have sepsis. If the study is able to demonstrate, through the use of the RNA-based diagnostic test, that it is possible to identify patients with sepsis who are at risk of poor outcomes then that could enable a more personalised medicine approach to the treatment of sepsis. 
For the participants in the study there may be no apparent, direct benefit as there is no change to the patient's standard care and treatment because the study is observational and test results will not be shared with the research team or influence care. That said, these participants would be the type of patient that stand to benefit most from research into their condition and future improvements in treatment and care for sepsis. 

Additional information