Comparison of extracorporeal liver support systems MARS and SPAD in a cross over design

Comparison of extracorporeal liver support systems MARS and SPAD in a cross over design - MARS/SPAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000371

Enrollment

Registered

2010-04-08

Start date

2010-08-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute and acut-on-chronic liver failure K70 K77 T86.4 K71 K72 K73 K74 K75 K76 B15-B19 E83.0 E83.1

Interventions

Group 1: Crossover-Design: On day 1 treatment A: albumin dialysis with MARS, for ca. 8 hours, then on day 2 treatment B: albumin dialysis with SPAD, for ca. 7 hours Group 2: Crossover-Design: On da

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - acute or acute-on-chronic liver failure - Serum bilirubin > 8-10 mg/dl ( 136-171 µmol/l) und plasma disappearance rate of indocyanine green (PDRICG) < 8-10 %

Exclusion criteria

Exclusion criteria: Age below 18 years

Design outcomes

Primary

Measure	Time frame
Changes of serum bilirubin concentrations, blood samples before and after albumin dialysis	—

Secondary

Measure	Time frame
Changes of other laboratory parameters before and after each cycle of albumin dialysis: blood samples for laboratory parameters (albumin binding capacity, bile acids, indols, phenols, ammonia, Liver parameters (ASAT, ALAT, GLDH, GGT, AP), albumin, total proteins, lactate, creatinine, urea, blood count (hb, hct, WBC, thrombocytes), coagulation parameters (prothrombin ratio, PTT, factor V, fibrinogen, antithrombin), electrolytes (sodium, potassium, calcium), cytokines, vasoactive substances, etc.) \|\| classification of hepatic encephalopathy grade before and after each cycle of albumin dialysis (HE-grade; in awake patients additionaly determination with:"Hepatic Encephalopathy Scoring Algorithm") \|\| organ dysfunction before and after each cycle of albumin dialysis (SOFA-Score, catecholamine dose, cardiac output (assessment with PiCCO) \|\| plasma disappearance rate of indocyanine green (PDR-ICG; assessment with LiMON) before and after each cycle of albumin dialysis	—

Measure

Time frame

Changes of other laboratory parameters before and after each cycle of albumin dialysis: blood samples for laboratory parameters (albumin binding capacity, bile acids, indols, phenols, ammonia, Liver parameters (ASAT, ALAT, GLDH, GGT, AP), albumin, total proteins, lactate, creatinine, urea, blood count (hb, hct, WBC, thrombocytes), coagulation parameters (prothrombin ratio, PTT, factor V, fibrinogen, antithrombin), electrolytes (sodium, potassium, calcium), cytokines, vasoactive substances, etc.) || classification of hepatic encephalopathy grade before and after each cycle of albumin dialysis (HE-grade; in awake patients additionaly determination with:"Hepatic Encephalopathy Scoring Algorithm") || organ dysfunction before and after each cycle of albumin dialysis (SOFA-Score, catecholamine dose, cardiac output (assessment with PiCCO) || plasma disappearance rate of indocyanine green (PDR-ICG; assessment with LiMON) before and after each cycle of albumin dialysis

—

Countries

Germany

Contacts

Public ContactMichael Bauer

Klinik für Anästhesiologie und Intensivtherapie Universitätsklinikum Jena

Michael.bauer@med.uni-jena.de+49-3641-9323111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026