Recompensation of exacerbated liver insufficiency with hyperbilirubinaemia and/or encephalopathy and/or renal failure

ISRCTN	ISRCTN67377557
DOI	https://doi.org/10.1186/ISRCTN67377557
ClinicalTrials.gov number	NCT00614146
Secondary identifying numbers	1438

Submission date: 17/01/2006
Registration date: 23/02/2006
Last edited: 07/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rafael Bañares
Scientific

Hospital General Universitario
Servicio de Gastroenterología (Sección de Hepatología)
C/ Dr Esquerdo, 46
Madrid
28007
Spain

Study information

Study design	Randomised prospective open controlled non-blinded two-armed study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Recompensation of Exacerbated Liver Insufficiency with hyperbilirubinaemia and/or Encephalopathy and/or renal Failure
Study acronym	RELIEF
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
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 study start date	16/04/2003
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	172
Key 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)
Key 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
Date of first enrolment	16/04/2003
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Austria
Belgium
Denmark
France
Germany
Italy
Spain
Switzerland
United Kingdom

Study participating centre

Hospital General Universitario

Madrid
28007
Spain

Sponsor information

Gambro Lundia AB (Sweden)
Industry

Study Director Ludger Thiele
PO Box 1010
Magistratsvägen 16
Lund
22010
Sweden

Phone	+33 (0)437 281 135
Email	ludger.thiele@gambro.com
Website	http://www.gambro.com
"ROR"	https://ror.org/05mw5ed57

Funders

Funder type

Industry

Gambro Lundia AB (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2013	07/02/2019	Yes	No

Editorial Notes

07/02/2019: Publication reference added.
08/06/2017: No publications found, verifying study status with principal investigator.
10/12/2007: The overall trial end date was changed from 01/08/2007 to 01/09/2008.