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

Primary Purpose

Variceal Rebleeding Rate and Infections

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial

About this trial

This is an interventional treatment trial for Variceal Rebleeding Rate and Infections

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination..
Age ranges between 20-80 y/o.
Patients presenting with hematemesis and /or melena within 24 hours of inclusion.
Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection.
-

Exclusion Criteria:

Uncertain of bleeding source.
Failure in endoscopic therapy.
Had variceal bleeding or peptic ulcer bleeding in recent one month
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

Sites / Locations

E-Da HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Gruoup B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

incidence of very early rebleeding

The occurrence of variceal rebleeding after initial hemostasis

Secondary Outcome Measures

Bacterial infections, 42-day rebleeding, mortality

Incidence of bacterial infections & rebleeding, mortality in 6 weeks

Full Information

NCT ID

NCT04056806

First Posted

August 6, 2019

Last Updated

August 13, 2019

Sponsor

E-DA Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04056806

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 2019 (Anticipated)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

E-DA Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Variceal Rebleeding Rate and Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

A prospective, randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Gruoup B

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial

Other Intervention Name(s)

Ceftriaxone 1gm

Intervention Description

efficacy comparison between 2 days and 5 days

Primary Outcome Measure Information:

Title

incidence of very early rebleeding

Description

The occurrence of variceal rebleeding after initial hemostasis

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Bacterial infections, 42-day rebleeding, mortality

Description

Incidence of bacterial infections & rebleeding, mortality in 6 weeks

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination.. Age ranges between 20-80 y/o. Patients presenting with hematemesis and /or melena within 24 hours of inclusion. Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection. - Exclusion Criteria: Uncertain of bleeding source. Failure in endoscopic therapy. Had variceal bleeding or peptic ulcer bleeding in recent one month 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gin-Ho Lo, M.D.

Phone

975-106-200

ghlo@kimo.com

Facility Information:

Facility Name

E-Da Hospital

City

Kaohsiung

ZIP/Postal Code

824

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gin-Ho Lo

Phone

975-106-200

ghlo@kimo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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