Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at whether a combination of two medications, midodrine and albumin, can help prevent serious health problems in children with liver cirrhosis and fluid buildup in the abdomen (a condition known as ascites). Children with cirrhosis often face complications that can worsen their health and may even prevent them from receiving a liver transplant. Midodrine helps increase blood pressure and improve kidney function, while albumin is a protein that helps keep blood volume steady and has anti-inflammatory effects. The researchers want to see if using these two treatments together will be more beneficial than using either one alone.

To participate in this trial, children must be 18 years old or younger and have a confirmed diagnosis of cirrhosis along with significant fluid buildup. Parents or guardians will need to provide consent for their child to join the study. It's important to note that children with certain health issues, like high blood pressure or severe heart problems, won't be eligible. Participants will be monitored closely throughout the trial to assess how well the combination of medications works and to ensure their safety. This study aims to find better ways to manage cirrhosis complications in children, ultimately improving their chances of survival and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Children (≤ 18 years)
• • 2. Cirrhosis based on histological/ radiological + endoscopic evidence
• • 3. Clinical ascites (≥ grade 2 ascites)
• • 4. Informed consent from parents (Assent \> 12 years)
• Exclusion Criteria:
• • 1. Arterial hypertension (Mean Arterial Pressure ≥ 95th centile for age)
• • 2. Presence of Portal vein thrombosis
• • 3. Hepatorenal Syndrome
• • 4. Congestive Heart failure
• • 5. Respiratory failure(PF ratio \<200)
• • 6. Septic shock
• • 7. Presence of Hepatocellular Carcinoma
• • 8. Transjugular intrahepatic Porto Systemic Shunt