Clinical trial NCT04058613: Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites
Official title: Effects of Maintaining Steady Albumin Levels by Targeted Albumin Therapy (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites and Low Serum Albumin Level- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transplant/Transintrahepatic Portosystemic Shunt (TIPS) free survival in both groups
timeFrame: 12 months
Secondary outcomes:
measure: New onset refractory ascites in both the groups
timeFrame: 12 months
measure: Spontaneous bacterial peritonitis [SBP] in both groups
timeFrame: 12 months
measure: Renal impairment in both groups
timeFrame: 12 months
measure: Hepatorenal Syndrome in both groups
timeFrame: 12 months
measure: Hepatic encephalopathy grade 3 or 4 in both groups
timeFrame: 12 months
measure: Number of new cases with gastrointestinal bleeding in both groups
timeFrame: 12 months
measure: Requirement of paracentesis in both groups
timeFrame: 12 months
measure: Requirement of diuretics in both groups
timeFrame: 12 months
measure: Number of hospitalizations per subject in both groups
timeFrame: 12 months
measure: New onset breathlessness/ Hypertension within 24 hours of albumin infusion in both groups
timeFrame: within 24 hours
measure: Quality of life by Ascite-Q questionnaire in both groups
timeFrame: 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: