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

NCT ID: NCT04056806

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2022-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

receiving terlipressin 2mg bolus on enrollment followed by 1mg per 6 hours. Both Terlipressin infusion and Ceftriaxone continue till 48 hours after endoscopic therapy

Group Type: EXPERIMENTAL

Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial

Intervention Type: DRUG

efficacy comparison between 2 days and 5 days

Gruoup B

receiving terlipressin 2mg bolus instituted on enrollment followed by 1mg per 6 hours. Ceftriaxone 1gm intravenously dose of ceftriaxone 1gm at 24 h interval. Both Terlipressin infusion and Ceftriaxone continue till 5 days after endoscopic therapy.

Group Type: ACTIVE_COMPARATOR

Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial

Intervention Type: DRUG

efficacy comparison between 2 days and 5 days

Interventions

Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial

efficacy comparison between 2 days and 5 days

Intervention Type: DRUG

Other Intervention Names

Ceftriaxone 1gm

Eligibility Criteria

Inclusion Criteria

1. Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination..

2. Age ranges between 20-80 y/o.

3. Patients presenting with hematemesis and /or melena within 24 hours of inclusion.

4. Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection.

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Exclusion Criteria

1. Uncertain of bleeding source.

2. Failure in endoscopic therapy.

3. Had variceal bleeding or peptic ulcer bleeding in recent one month

4. has evidence of bacterial infections or possible infection at entry ( such as fever > 37.5。 C, white blood cells> 10000/cumm, urine leukocytes >10/ field, pneumonic patches on chest x-ray, ascitic polymorphonuclear cells > 250/cumm, cellulitis or other focal infections).

2) ever received antibiotics within 4 weeks before index upper gastrointestinal bleeding.

3) presence of cardiopulmonary embarrassment 4) association with uremia and receiving hemodialysis or peritoneal dialysis. 5) presence of deep jaundice (serum bilirubin > 10 mg/dl), hepatic encephalopathy stage III or IV, massive or refractory ascites 6) presence of chronic kidney disease ( serum creatinine > 2 mg/dl) or hepatorenal syndrome 7) Had history of cerebrovascular accident, coronary artery disease, complete AV block or peripheral vascular disorder 6) association with human immunodeficiency virus (HIV) infection, advanced carcinoma or hepatocellular carcinoma Barcelona Club Liver Cancer (BCLC) class C or D.

7) allergy to terlipressin, cephalosporins or penicillin 8) pregnancy. 9) Uncooperative or decline to be enrolled

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• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

E-DA Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

E-Da Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Gin-Ho Lo, M.D.

Role: CONTACT

ghlo@kimo.com

975-106-200

Facility Contacts

Gin-Ho Lo

Role: primary

ghlo@kimo.com

975-106-200

Other Identifiers

EMRP39107N

Identifier Type: -

Identifier Source: org_study_id