Comparison of administrative methods of terlipressin for esophageal variceal bleeding

A prospective multicenter study for comparison of standard dose repeated bolus injection vs. low dose continuous intravenous infusion of terlipressin for acute esophageal variceal bleeding in patients with liver cirrhosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006107

Enrollment

126

Registered

2021-04-29

Start date

2022-01-27

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In Group A, 1.0 mg of terlipressin was administered intravenously every 6 hours (4 times a day) for 72 hours, and Group B was infused continuously with 2.0 mg terlipressin mixed in saline 250 m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Age of 25-75 years ? patients with liver cirrhosis ? the cases with active bleeding or suspected stigma on esophageal varix

Exclusion criteria

Exclusion criteria: ? If the selection criteria are not satisfied ? Those with hypersensitivity to terlipressin or contraindications such as ischemic heart disease. ? Gastric variceal bleeding (fundal gastric variceal bleeding, i.e., IGV or GOV2 and the bleeding point is in the stomach and bottom), variceal bleeding on the esophago-gastric junction can be registered. ? When endoscopic variceal obturation (EVO) is required ? When radiological intervention such as BRTO (balloon occluded retrograde transvenous variceal obliteration) or TIPS (transjugular intrahepatic portosystemic shunt) is required ? When compression hemostasis using balloons such as SB tube is necessary ? Those whose vital signs are unstable and unable to perform emergency endoscopy within 24 hours ? Hepatocellular carcinoma exceeding the Milan standard ? Untreated malignant tumor ? Hepatic encephalopathy of stage 3 or higher ? Those who have undergone treatment for esophageal varices within the last 4 weeks ? HIV-infected patients ? Pregnant women, nursing women, and women of childbearing age who do not have the will of contraception. ? Those who do not have the ability to sign the consent form

Design outcomes

Primary

Measure	Time frame
Treatment success rate in both groups	—

Secondary

Measure	Time frame
Severity and incidence of adverse drug reactions;Survival of cirrhotic patients with variceal bleeding;occurrence of cirrhosis complications;Economic evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactTaeHyung Kim

Korea University Ansan Hospital

lacid81@gmail.com+82-31-412-5580

Outcome results