Liver Cirrhosis
Conditions
Brief summary
Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (\<2.8g/dl) with ascites.
Detailed description
Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-\<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.
Interventions
DRUGALB Protein, Human
Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy
OTHERplacebo
placebo
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Newly detected cirrhotic patients aged more than 18 years * Cirrhosis defined by standard clinical, analytical and/or histological criteria * Serum albumin level \< 2.8g/dl with or without ascites * Who would agree to give written informed consent
Exclusion criteria
* Uncontrolled HTN (sys\>150/ dis \>90 mmHg) or h/o any drug therapy for HTN * Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS) * Hepatocellular Carcinoma * Active alcohol abuse within 3 months * Patients presenting as Acute on Chronic Liver Failure * Extrahepatic organ failure * Known case of chronic heart failure or respiratory failure * Diagnosed Chronic Kidney Disease * Patients with hydrothorax * Prior liver transplant recipient * Human Immunodeficiency Virus infection * Use of albumin infusion in the last one month * CTP\>12, MELD\>28 * Total Bilirubin \>3 g/dl * Overt Hepatic Encephalopathy at Presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups | 12 months | 1 year survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous bacterial peritonitis [SBP] in both groups | 12 months | Spontaneous bacterial peritonitis is defined as ascitic fluid absolute neutrophil count \> 250/ mL with or without culture positivity |
| Renal impairment in both groups | 12 months | serum creatinine concentration \>1•5 mg/dL |
| Hepatorenal Syndrome in both groups | 12 months | Hepatorenal Syndrome type 1 is defined as new onset increase in serum creatinine level by 0.3 mg/dL or 50% increase from baseline |
| Hepatic encephalopathy grade 3 or 4 in both groups | 12 months | HE as per West Haven criteria |
| Number of new cases with gastrointestinal bleeding in both groups | 12 months | gastrointestinal bleeding as confirmed by endoscopic/clinical evidence of variceal bleed. |
| New onset refractory ascites in both the groups | 12 months | refractory ascites is defined as non response to maximum tolerated dose of diuretics |
| Requirement of diuretics in both groups | 12 months | Frusemide or Aldactone for management of ascites |
| Number of hospitalizations per subject in both groups | 12 months | Need for any cause hospitalization |
| New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups | within 24 hours | Development of cardiac overload |
| Quality of life by Ascite-Q questionnaire in both groups | 12 months | semiquantitative questionnaire to be answered by the participants |
| Requirement of paracentesis in both groups | 12 months | Ascitic tapping for relieve of pressure symptoms or diagnosis of SBP |
Countries
India
Contacts
Primary ContactDr Shasthry SM, MD
Outcome results
None listed