Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00614146
Protocol/serial number
1438
Study information
Scientific title
Recompensation of Exacerbated Liver Insufficiency with hyperbilirubinaemia and/or Encephalopathy and/or renal Failure
Acronym
RELIEF
Study hypothesis
Patients with Molecular Adsorbents Recirculation System (MARS®) treatments in addition to standard medical treatment show a significant improvement in 28-day transplant-free survival.
Ethics approval
Ethics approval received from the Freiburg Ethics Commission International (first review) on the 02/04/2003. Local Ethics Committee approval sought for every study site.
Study design
Randomised prospective open controlled non-blinded two-armed study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Recent clinical severe decompensation of a presumed cirrhosis related to a precipitating event
Intervention
Comparison of standard medical treatment (SMT) for acute-on-chronic liver failure versus MARS® liver support therapy in addition to SMT.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
28-day transplant-free survival
Secondary outcome measures
1. 28-day survival regardless of transplantation
2. 84-day survival
3. In-hospital mortality
4. Time course of clinical state (number and severity of complications, vital signs, scoring systems, laboratory tests)
5. Economic analysis
Overall trial start date
16/04/2003
Overall trial end date
01/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Signed written informed consent by patient or next of kin
2. Age greater than 18 years
3. Patients with a recent clinical severe decompensation of a presumed cirrhosis (based on clinical evaluation or radiological imaging) related to a precipitating (trigger) event (e.g. infection, bleeding, alcohol abuse)
4. Intrahepatic cholestasis (bilirubin greater than 5 mg/dl or greater than 85 µmol/l, respectively) without evidence of extrahepatic origin and at least one of the following three:
4.1. Hepatorenal syndrome (impaired renal function with creatinine greater than 1.5 mg/dl or greater than 133 µmol/l without evidence of reduced vascular volume [e.g. central venous pressure {CVP} greater than 8 cm H2O] and no evidence of pre-existing renal failure)
4.2. Hepatic Encephalopathy greater than or equal to II°
4.3. Progressive Hyperbilirubinaemia: defined as a more than 50% increase of bilirubin before enrolment, whether in referral or currently in hospital up to a level of greater than 20 mg/dl (or greater than 340 µmol/l)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
172
Participant exclusion criteria
1. Progressive jaundice and deterioration as a natural course of a chronic liver disease without precipitating (trigger) event
2. Severe thrombocytopenia (platelet count less than or equal to 50 glutamic pyruvic transaminase [GPT]/l)
3. Severe coagulopathy (international normalised ratio [INR] greater than 2.3)
4. Need for renal replacement therapy within three days prior to enrolment
5. Severe infection without antibiotic treatment for at least 24 hours. Uncontrolled bacterial infection.
6. Active bleeding within 48 hours prior to enrolment
7. Proven hepatocellular carcinoma (HCC) greater than 4 cm or infiltration of portal vein or acute portal vein thrombosis
8. Severe cardiopulmonary disease (New York Heart Association [NYHA] greater than or equal to 2)
9. Pregnancy/lactation
10. Mean arterial pressure (MAP) less than 60 mmHg despite vasopressor agents (norepinephrine greater than 1 µg/kg/min) for blood pressure support
11. Overt clinical evidence for disseminated intravascular coagulation (DIC)
12. Clinical evidence for coma of non-hepatic origin
13. Extra-hepatic cholestasis
14. Severe intrinsic renal disease
15. Extended surgical procedure within the last four weeks or unsolved surgical problems
16. Known human immunodeficiency virus (HIV) infection
Recruitment start date
16/04/2003
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Austria, Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom
Trial participating centre
Hospital General Universitario
Madrid
28007
Spain
Sponsor information
Organisation
Gambro Lundia AB (Sweden)
Sponsor details
Study Director Ludger Thiele
PO Box 1010
Magistratsvägen 16
Lund
22010
Sweden
+33 (0)437 281 135
ludger.thiele@gambro.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Gambro Lundia AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list