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Product name

Hepatocyte-based test for monitoring toxins and the determining of liver function in sepsis from University Hospital of Rostock

Summary

Standardized MT-plate based tetst allows the exact and fast determination of sepsis relevant parameters

Organization name

PVA-MV AG

Profile

Sepsis, systemic inflammatory response syndrome and septic shock are major challenges in ICUs.These afflictions of the body can result in liver failure and cause a high lethality. The best therapeutic strategy is difficult to determine due to additive effects of multiple toxins, a limited therapeutic time window and the very often unknown predisposition of patients. The fast deterioration of patient status leads to chronic damages and very costly treatments.

Determining the effects of new pharmaceutical agents on the liver is costly, time consuming and up to now not reliable. Several new drugs had to be withdrawn after market introduction due to liver toxicity not detected during drug development.

Side effects due to the combination of well established drugs are difficult to predict. This is especially important in cases of multi-morbidity and chronic diseases.

There is a broad need for the timely and clinically relevant measurement of the liver status as well as of the effect of toxins on the liver.

Innovation

A team at the University Hospital of Rostock ICU developed a MT-plate based test allowing the exact and clinically relevant determination of

the patient´s liver status
the effect of multiple toxins on the liver.

Standardised hepatocyte cell lines (ATCC), which are well characterized due to their use in extracorporal liver support systems, are exposed to a patient´s serum. Subsequently, a suite of parameters is determined.

Results of the assay are available within less than 24 hours. A 28 sepsis patient study showed a strong correlation of the parameters to clinical findings. Cut-off values have been defined. Enrollment for a larger (two arms 50 patients each) study has been completed recently.

Parameter

Due to the fact that the test is based on hepatocytes, an evidence of the damage on the livers cellular level is possible. As the hepatocytes are highly sensitive, fast changes in the test parameters can be observed.
Parameters are:

Activity: cytochrome 1A2 activity (metabolism of etoxyresorufin)
Function: synthesis of albumin
Viability of cells: Live/Dead-Test; XTTTest; LDH release

Value