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 (NCT) | NCT00614146 |
| Protocol serial number | 1438 |
| Sponsor | Gambro Lundia AB (Sweden) |
| Funder | Gambro Lundia AB (Sweden) |
- 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
Scientific
Hospital General Universitario
Servicio de Gastroenterología (Sección de Hepatología)
C/ Dr Esquerdo, 46
Madrid
28007
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised prospective open controlled non-blinded two-armed study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
28-day transplant-free survival |
| Key secondary outcome measure(s) |
1. 28-day survival regardless of transplantation |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Austria
- Belgium
- Denmark
- France
- Germany
- Italy
- Spain
- Switzerland
Study participating centre
Hospital General Universitario
Madrid
28007
Spain
28007
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
