Safety of citrate calcium anti-coagulation system and its use for liver insufficiency

Not Applicable

Completed

• Conditions: iver insufficiency; Digestive System; Hepatic failure, unspecified

• Registration Number: ISRCTN31779998
• Lead Sponsor: Danube University Krems (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-13
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Both males and females with age: 18-75 years
2. Serum Bilirubin > 5 mg/dL (more than 72 h)
3. Model for End Stage Liver Disease (MELD) > 30 (more than 72 h) or
4. Therapeutic resistant hepatic encephalopathy = II° or
5. Therapeutic resistant kidney failure (requiring dialysis) or
6. Therapeutic resistant alcoholic hepatitis or
7. Therapeutic resistant pruritus [Visual Analogue Scale (VAS) > 7]

Exclusion Criteria

1. INR > 3
2. Thrombocytes < 30,000
3. Multiorgan failure (liver and > 3 organs)
4. M ean arterial pressure (MAP) < 55 mmHg
5. Acute bleeding (>4 Erythrocyte concentrates in the last 24 hours)
6. Extra hepatic cholestasis

Therapeutic resistance:
1. Hepatic Encephalopathy: Lactulose 60g/d and Ornithin-Aspartate 20g/d i.v. within 72h
2. Kidney failure: volume support albumin 1g/kg-KG, Terlipressin (3 mg/d) within 72h
3. Alcoholic hepatitis: Prednislon 40 mg within 7 days and Lille Score >0.45
4. Pruritus: Cholestyramin 8g and Naltrexone 50 mg within 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified