Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure (MARSPAD)
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About
A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.
This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and >400µmol/L).
Enrollment
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Inclusion criteria
- severe hepatic failure on acute liver failure or acute on chronic liver failure
- hyperbilirubinemia (total plasmatic bilirubin level above 250µmol/L)
- hepatic encephalopathy or pruritus or hepatorenal syndrome.
- waiting for liver function recovery or liver transplantation
- Signed written informed consent by patient or patient's legally appointed representative or reliable person
- affiliation to social security
Exclusion criteria
- contraindication to extra-renal epuration
- hypersensibility to albumin or excipients
- patients for whom 2 albumin dialysis treatment cannot be considered
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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