NCT04056806

2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Control Acute Gastroesophageal Variceal Hemorrhage

A Prospective, Randomized Controlled Trial of 2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Prevention of Very Early Rebleeding in Patients With Acute Gastroesophageal Variceal Hemorrhage

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: E-DA Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding has been a routine clinical practice . It is still unknown whether use of short term vasoconstrictors and antibiotics could have superior acute hemostatic rate. Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastro-esophageal variceal hemorrhage..

Detailed description

Acute gastro-esophageal variceal hemorrhage is a dreadful complication of portal hypertension. Meta-analysis showed that the combination of vasoconstrictor and endoscopic therapy is superior to endoscopic therapy or vasoconstrictor alone in the control of acute esophageal variceal hemorrhage. Bacterial infections are frequently encountered in cirrhotic patients presenting with acute upper gastrointestinal bleeding. The association of bacterial infections to variceal bleeding may increase the occurrence of variceal rebleeding and mortality. A study has shown that antibiotic prophylaxis in patients with acute esophageal variceal hemorrhage may reduce infection as well as prevent rebleeding. Currently, most guidelines recommend that vasoactive drugs should be continued for 3 to 5 days after endoscopic therapy and antibiotics should be instituted for up to 7 days to manage patients with acute esophageal variceal hemorrhage . On the other hand, some studies in recent years implied that short term vasoconstrictors or antibiotics could achieve similar low variceal rebleeding rates. The use of prophylactic antibiotics in cirrhotics with gastrointestinal bleeding for only one single dose or 3 days appeared to be feasible. It is still unknown whether use of short term both vasoconstrictors and antibiotics could have similar acute hemostatic rate. Thus, the investigators conducted a trial to compare the effectiveness between participants receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after endoscopic therapy in cirrhotic patients presenting with acute gastroesophageal variceal hemorrhage..

Conditions

• Variceal Rebleeding Rate and Infections

Interventions

Type	Name	Description
DRUG	Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial	efficacy comparison between 2 days and 5 days

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2019-08-14
• Last updated: 2019-08-14

Locations

1 site across 1 country: Taiwan