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NCT05699824
To Study the Hemodynamic Response of Early Addition of Carvedilol to Terlipressin in Acute Variceal Bleed in Child's B and C Cirrhosis
Conditions: Liver Cirrhosis
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 100
Sponsor: Institute of Liver and Biliary Sciences, India
Location: India
Summary
Management of Acute variceal bleeding includes endoscopic variceal ligation (EVL) along with vasoactive agents.
Inspite of successful hemostasis, this is associated with high variceal rebleeding (VRB) in Child B and C cirrhosis and have higher 6-week mortality rates.
Pre-emptive TIPS has shown to prevent rebleed and improve survival in child B and C patients but is associated with liver related complications in advanced disease.
HVPG guided therapy and treatment response is known to improve rebleeding and associated with improved survival.
This is based on achieving hemodynamic response defined as HVPG reduction of ≥20% from baseline or absolute reduction of HVPG </= 12 mmHg for secondary prophylaxis for prevention of rebleeding.
Studies have shown the safety of giving terlipressin in patients receiving beta- blockers.
We aim to achieve hemodynamic response with addition of carvedilol with vasoactive agent for reduction of portal blood flow to decreases rebleeding episodes and reduce mortality.
Eligibility Criteria
Inclusion Criteria:Cirrhosis with Acute Variceal BleedChild's B and C cirrhosis (CTP ≤ 12)Patients age between 18 to 75 yearsExclusion Criteria:Gastric variceal bleedBleeding related to coagulopathyOther causes of portal hypertensive bleedingAcute on chronic liver failureSepsisShock(persistence of hypotension)Acute kidney injury (>1.5 mg%)Grade 3 AscitesHyponatremia (Na < 125 mEq/L)Complete portal vein thrombosisHepatocellular carcinoma (>3cm lesion)Tumoral portal vein thrombosisChronic kidney diseaseCoronary artery diseaseValvular heart diseaseSick sinus syndrome/ PacemakerArrythmiaUncontrolled hypothyroidism and hyperthyroidismPregnancyFailure to give consent
Source: ClinicalTrials.gov (NCT05699824). StuddyBuddy aggregates publicly available trial information.