Improved diagnosis of sepsis-related hepatic dysfunction with the LiMAx test
Prospective study showed superior sensitivity and specificity of the LiMAx test compared to traditional tests and its value as predictor of survival
Sepsis is a frequent infection with high mortality rates in intensive care units (ICU) and may occur in approximately 25% of ICU patients. Multiple organ failure caused by sepsis still remains the most frequent cause of death in intensive care. Hepatic dysfunction and liver failure deriving from severe sepsis might be associated with poor prognosis in critically ill patients. A prospective clinical study showed that sepsis-related hepatic dysfunction can be diagnosed early and effectively by the LiMAx test. The extent of LiMAx impairment is predictive for patient morbidity and mortality. The sensitivity and specificity of the LiMAx test was superior to that of the indocyanine green test regarding the prediction of survival.
Erwin de Buijzer, Managing Director of Humedics GmbH, comments the positive study results: “In this study, our LiMAx breath test was investigated for the diagnosis of sepsis-related liver dysfunction for the first time and the results show that the test provides an early and more precise diagnosis for these critically ill patients. We are pleased that we can extend the indications for this new and sophisticated diagnostic tool and expect that the LiMAx test will find its way into the intensive care for improved diagnosis and treatment of sepsis patients.”
Study results clearly showed that septic shock leads to deterioration of LiMAx within two days after onset of sepsis in the vast majority of patients. Furthermore, the degree of functional impairment determined by the LiMAx test is closely related with the patient’s prognosis. In addition, follow up LiMAx allowed the determination of individual progress of the patients. PD Dr. Martin Stockmann from Charité – Universitätsmedizin Berlin at the Campus Virchow Hospital, Dept. of General, Visceral and Transplantation Surgery, explains: “The LiMAx test directly measures the liver function via the capacity of the liver specific cytochrome P450 enzyme system and thus provides reliable results on the metabolic capacity of the liver. This has not been possible until now with other tests described.” Stockmann assumes that the impact of hepatic dysfunction on therapy during sepsis may be underestimated at present. With respect to the potential toxicity of administered drugs in patients with organ failures, he concludes: “Therapy schemes and drug dosage may be adapted due to the liver function capacity. This could lead to an optimized therapy of the patient in this critical situation”
28 patients suffering from sepsis on a surgical ICU were investigated prospectively. All patients received routine sepsis therapy according to current sepsis guidelines (surgery, fluids, catecholamines, antibiotic drugs). The first LiMAx test was carried out within the first 24 hours after onset of septic symptoms, followed by day 2, 5 and 10. Other biochemical parameters and scores determining the severity of illness were measured daily. Clinical outcome parameters were examined after 90 days or at the end of treatment. The population was divided into 2 groups (group A: non- survivors or ICU length of stay (ICU-LOS) >30 days versus group B: survivors and ICU-LOS <30 days) for analysis.
The study was performed at Charité – Universitätsmedizin Berlin, Campus Virchow Hospital, Dept. of General, Visceral and Transplantation Surgery.
Original publication: Critical Care 2013, 17:R259 doi:10.1186/cc13089
Humedics has developed a breath test based in vivo diagnostic system (the LiMAx® test), which comprises a CE-marked medical device, breathing masks and a diagnostic drug. The LiMAx® test enables the clinician to quantitatively determine the individual liver function capacity of a patient within minutes. This allows for selection of treatment strategies and disease monitoring optimally adapted to the individual patients’ liver status. Current clinical applications, studies of which have already been published in highly respected peer-reviewed scientific journals, include diagnosis of the liver function before and after liver transplantation, liver surgery planning (e.g. assessment of the amount of liver to be resected without potentially increasing the risk of acute liver failure) and assessment of diseases such as liver fibrosis and cirrhosis. Over 20 trials in new indications such as the diagnosis of chronic liver diseases like non-alcoholic steatohepatitis (NASH) and the improvement of treatment decisions in liver oncology are ongoing. These investigator initiated trials impressively demonstrate the further potential of the LiMAx® test. The LiMAx® test is already being used in over 30 top-tier university clinics across Europe and more than 20,000 tests have already been performed. The LiMAx® test is commercially available in Germany, Austria and the UK.
Based on the specific metabolic action of the liver enzyme CYP1A2, which is expressed in all functioning hepatocytes, performing the LiMAx® test is a simple procedure. The diagnostic drug solution is administered intravenously, and the liver immediately starts to metabolize the drug into low dose paracetamol and 13CO2 (non-radioactive). The latter is exhaled in the breath, collected via a respiratory mask and guided to the LiMAx® system where, within 1-2 minutes following the injection, the LiMAx® IR laser spectroscopy system allows real-time and very precise quantification of the increase in 13CO2 content. The resulting LiMAx® value, measured in micrograms per kilo body weight per hour, is a reliable and repeatable measure of the maximum functional capacity of the liver.
Erwin de Buijzer MD MBA
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