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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
304
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
placebo
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGTransplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
1 year survival
Time frame: 12 months
New onset refractory ascites in both the groups
refractory ascites is defined as non response to maximum tolerated dose of diuretics
Time frame: 12 months
Spontaneous bacterial peritonitis [SBP] in both groups
Spontaneous bacterial peritonitis is defined as ascitic fluid absolute neutrophil count \> 250/ mL with or without culture positivity
Time frame: 12 months
Renal impairment in both groups
serum creatinine concentration \>1•5 mg/dL
Time frame: 12 months
Hepatorenal Syndrome in both groups
Hepatorenal Syndrome type 1 is defined as new onset increase in serum creatinine level by 0.3 mg/dL or 50% increase from baseline
Time frame: 12 months
Hepatic encephalopathy grade 3 or 4 in both groups
HE as per West Haven criteria
Time frame: 12 months
Number of new cases with gastrointestinal bleeding in both groups
gastrointestinal bleeding as confirmed by endoscopic/clinical evidence of variceal bleed.
Time frame: 12 months
Requirement of paracentesis in both groups
Ascitic tapping for relieve of pressure symptoms or diagnosis of SBP
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Requirement of diuretics in both groups
Frusemide or Aldactone for management of ascites
Time frame: 12 months
Number of hospitalizations per subject in both groups
Need for any cause hospitalization
Time frame: 12 months
New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups
Development of cardiac overload
Time frame: within 24 hours
Quality of life by Ascite-Q questionnaire in both groups
semiquantitative questionnaire to be answered by the participants
Time frame: 12 months