Efficacy of Proton Pump Inhibitors in Cirrhotic Patients With Acute Variceal Bleeding

NCT05624229 | Not Yet Recruiting Phase 4

• 1 other identifier: PPI-AVB
• Study Type: interventional
• Target: 672
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute Variceal Bleeding (AVB) in patients with liver cirrhosis is a common clinical critical disease. There is little evidence for the effect of proton pump inhibitor (PPI) use in patients with AVB, and there is no study on the efficacy of PPI combined with standard therapy in patients with AVB.

Conditions

Upper Gastrointestinal Hemorrhage

Keywords

Proton Pump Inhibitors; Acute Variceal Bleeding; Liver Cirrhosis; Endoscopic Variceal Ligation

Outcome Measures

Primary Outcomes (1)

• 5-day treatment failure rate

  Failure of initial hemostasis Initial hemostasis was defined as not achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria. UGI bleeding occurred after initial hemostasis and within 5 days after enrollment was defined as early rebleeding. UGI bleeding was proven to be from esophageal varices.

  5 days

Secondary Outcomes (4)

• Rebleeding rate within 42 days

  42 days

• Mortality rate within 42 days

  42 days

• Rescure treatment

  42 days

• Compilcations

  42 days

Study Arms (2)

Standard group

PLACEBO COMPARATOR

Early treatment is mainly aimed at correcting hypovolemic shock, preventing gastrointestinal bleeding-related complications, effective control of bleeding, monitoring vital signs and urine output. Medical treatment included initiation and maintenance of vasoactive agents as soon as possible for 2 to 5 days, and prophylactic antibiotics (preferably ceftriaxone sodium or quinolones) by intravenous infusion for 5 days. Endoscopic intervention was performed within 12 hours after presentation and generally no longer than 24 hours. PPI was stopped immediately after endoscopic treatment. Early TIPS is determined according to the technology and concept of each unit.

Drug: No Proton Pump Inhibitors

Standard group+PPI

EXPERIMENTAL

PPI continued after endoscopic treatment for 5 days.

Drug: Proton Pump Inhibitors

Interventions

Proton Pump Inhibitors DRUG

PPI infusion continued to use for 5 days in experimental group

Also known as: Drug: Omeprazole, Drug: Esomeprazole, Drug: Rabeprazole, Drug: Pantoprazole, Drug: Ilaprazole, Drug: Lansoprazole

Standard group+PPI

No Proton Pump Inhibitors DRUG

PPI infusion stopped in standard group after endoscopy.

Standard group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis.
• The etiology of portal hypertension is cirrhosis.
• Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 24 hours.
• Be willing to participate in this clinical study, comply with the study requirements and sign the informed consent

You may not qualify if:

• non-cirrhotic portal hypertension
• the time from admission to endoscopy was more than 24 hours
• patients with peptic ulcer or gastroesophageal reflux disease requiring PPI therapy
• PPI use for more than 2 weeks before admission
• received endoscopic or interventional therapy within the previous 4 weeks
• PPI allergy
• Chronic renal insufficiency (CKD stage 3-5)
• Severe cardiopulmonary dysfunction (such as heart failure grade 3-4, respiratory failure, etc.)
• Hepatocellular carcinoma (Barcelona Clinic Liver Cancer (BCLC) stage C and D)
• other advanced malignancies (life expectancy less than 6 months)
• Pregnancy

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Liver Cirrhosis

Interventions

Proton Pump Inhibitors; Omeprazole; Esomeprazole; Rabeprazole; Pantoprazole; ilaprazole; Lansoprazole

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 22, 2022
• Study Start: October 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 28, 2023

Record last verified: 2023-09