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First clinical experience with a new type of albumin dialysis: the HepaWash® system

Introduction

Liver failure (LF) is associated with prolonged hospital stay, increased cost and substantial mortality. With regard to a limited number of donor organs, extracorporeal liver support is an appealing concept to bridge to transplant or to avoid transplant in case of recovery. A new type of albumin dialysis, the HepaWash® system, was recently introduced. The HepaWash® system provides rapid regeneration of toxin-binding albumin by secondary circuits altering binding capacities of albumin by biochemical (changing pH) and physical (changing temperature) modulation of the dialysate.

Methods

We evaluated the first 14 patients treated with the HepaWash® system with regard to safety and efficacy. Seven patients were treated in the context of the run-in phase of the studies (HEPATICUS 1 and HEPATICUS 2) and seven patients were treated since the HepaWash® system received the CE certificate in July 2013. Patients treated suffered under acute on chronic LF (n = 9) or secondary LF which resulted from nonhepatic diseases such as sepsis (n = 5). Primary endpoint: comparison of serum bilirubin, creatinine and serum BUN before and after the first treatment with the HepaWash® system. Statistics: IBM SPSS Statistics version 22. The Wilcoxon test for paired samples was used to detect significant treatment effects.

Results

A total of 254 treatments (1 to 101 per patient) were performed in 14 patients (six female, eight male). Mean age 54 ± 13. MELD score 33.7 ± 7.0, CLIF-SOFA 14.6 ± 2.7. Main underlying disease: nine acuteon-chronic LF; five secondary LF. While bilirubin did not change significantly on the day before HepaWash® treatment (26.2 ± 15.4 vs. 26.0 ± 15.4 mg/dl; P = 0.116), serum bilirubin levels were significantly decreased by the HepaWash® procedure (26.0 ± 15.4 vs. 17.7 ± 10.5 mg/ dl; P = 0.001). Similarly, serum creatinine (2.2 ± 0.8 vs. 1.6 ± 0.7 mg/dl; P = 0.005) and serum BUN (49.4 ± 23.3 vs. 31.1 ± 19.7 mg/dl; P = 0.003) were significantly lowered by the HepaWash® procedure. There were no serious adverse events observed in conjunction with the HepaWash® treatment.

Conclusion

So far the HepaWash® system has proven to be a safe and feasible procedure to effectively eliminate water and protein-bound toxins in humans with LF.

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Henschel, B., Schmid, R. & Huber, W. First clinical experience with a new type of albumin dialysis: the HepaWash® system. Crit Care 19, P383 (2015). https://doi.org/10.1186/cc14463

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Keywords

  • Liver Failure
  • Donor Organ
  • Serum Bilirubin
  • Significant Treatment Effect
  • Prolonged Hospital Stay