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Comparison of 3 Days and 7 Days Intravenous Ceftriaxone Prophylaxis for Variceal Bleeding

NCT00838864 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2015-08-31

No results posted yet for this study

Summary

Prophylactic antibiotics have been routinely recommended for cirrhotic patients with upper gastrointestinal bleeding recently. However, the regimen and duration of its use remain an inconclusive issue. Quinolones and 3rd generation cephalosporins have been more often used for prophyalxis recently. The duration for antibiotic usage were variable in the literatures, ranged from 4-10 days. The latest guideline from AASLD in 2007 was 7 days. In the survey of infections in cirrhotic patients with UGI bleeding performed by Bernard et al, most infections occurred in the first 5 days and half within the first 48 hours. Therefore, considering the cost-effectiveness and drug resistance issues, the necessity for such prophylaxis for 7 days may need to be re-evaluated.

The purpose of our study is to investigate the antibiotic prophylaxis duration for cirrhotic patients with acute gastro-esophageal variceal bleeding. We will enroll those patients suffering from variceal bleeding documented by endoscopic examination and without apparent evidence of infection. Those who have received antibiotics within 2 weeks, are less than 18 years old, get pregnant, have malignancy other than HCC, have allergy to ceftrioxone are excluded. After receiving well explanation and giving consent, these patients are randomly allocated to 2 groups and receive prophylactic antibiotic just after endoscopic examination; Group I: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II: receiving ceftriaxone 500 mg iv bolus stat and then q12h for 7 days. They will receive appropriate endoscopic treatment for gastro-esophgeal varices and glypressin 1mg q6h for 3 days. They will start to feed on the 2nd day if not contraindicated. The 2nd endoscopic treatment for varices will be performed 2 weeks later. We record the demographic data, vital signs, transfusion amount; check hemogram, U/A, CXR, ascites routine (with apparent ascites), classification of variceal size and Child-Pugh classification. We monitor the events of rebleeding \& infection, transfusion amount and hospitalization days We use rebleeding rate within 14 days as the primary end point. It is defined as the following events after initial stabilization of vital signs for 24 hours; (1): recurrence of hematemesis or bloody stool (2); need of transfusion more than 2 unit of blood and systolic pressure \< 100 mmHg or pulse rate \> 100/mn. We use infection rate during admission and mortality rate within 28 days as secondary end points.

Conditions

  • Esophageal and Gastric Varices
  • Gastrointestinal Hemorrhage

Interventions

DRUG

ceftrioxone

500 mg iv q12h for 3 days

DRUG

ceftrioxone

500 mg q12h for 7 days

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Tzong-Hsi Lee, M.D. · Far Eastern Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838864 on ClinicalTrials.gov