Breath Test for Patients with Acute Liver Disease

• Research type

  Research Study

• Full title

  Breath Test for Patients with Acute Liver Disease for early Detection of the Need for Transplant or Recovery

• IRAS ID

  17484

• Sponsor organisation

  Exalenz Bioscience Ltd

• Eudract number

  2009-011926-32

• ISRCTN Number

  N/A

• Research summary

  Decision making in the treatment of patients with severe acute liver disease is based on several clinical and laboratory parameters. Currently used parameters lack the ability to accurately assess liver function. Frequent determination of liver function is of importance in the follow-up of patients with acute liver disease. As blood tests may lag behind the actual liver state, a tool that directly assesses liver function may provide an earlier and more accurate prediction of disease trend compared with standard blood tests. Breath testing with 13C-labeled substrates provides a safe, non-invasive means for evaluating hepatic impairment in correlation with liver metabolic function. This study aims to provide data on a novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. This may enable the treating physicians to defer or activate patients on transplant priority/ super-urgent lists. A subset of these patients may even recover with no need for a transplant at all.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/62

• Date of REC Opinion

  21 Oct 2009

• REC opinion

  Further Information Favourable Opinion