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Comparison of 3 Days and 7 Days Intravenous Ceftriaxone Prophylaxis in Patients With Acute Variceal Bleeding

Phase 4
18 Years
Open (Enrolling)
Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

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Trial Information

Comparison of 3 Days and 7 Days Intravenous Ceftriaxone Prophylaxis in Patients With Acute Variceal Bleeding

1. Patient including & excluding Criteria Including: Those were diagnosed to have
gastro-esophageal variceal bleeding after endoscopic examination. No evidence
suggestive of infection was found including: 1)fever more than 37.5。C, 2)leucocytosis
with WBC > 15000 mm3 or immature neutrophils > 500 mm3, 3)PMN of ascites more than
250/mm3,4)urinalysis, WBC > 15 WBC/HPF, 5)suspected pneuminia in CXR.

Excluding:1)no consent 2)already has infection 3) antibiotic usage within 14 days 4)
less than 18 years old 5) pregnancy 6) has malignancy other than HCC 7) allergy to

2. Management, Allocation and Prophylaxis Those with esophageal variceal bleeding receive
edoscopic variceal ligation; those with gastric variceal bleeding receive Histoacryl
injection therapy. They all recieve glypressin 1mg q6h injection for 3 days and start
to feed on the second day if not contraindicated. We will perform 2nd session of
endoscopic treatment 14 days later. These patients will randomly alloacted to 2 groups
and recieve prophylactic antibiotic after 1st endoscopic treatment; Group I:
ceftriaxone 500 mg iv bolus stat and then q12h for 3 days, Group II: ceftriaxone 500 mg
iv bolus stat and then q12h for 7 days. If rebleeding occurs after allocation, further
treatment was decided by attending physician. If active infection occurs during
prophylaxis period and no improvement was observed for 24 hours, ceftriaxone use will
be stopped and further treatment was decided by attending physician.

3. Data record and Surveillance Data Record: We will record the basic data of the
patietns: including: age, sex, co-morbidity (CAD, heart failure, COPD, chronic liver
and renal diseases, malignancy, etc);hemogram before allocation,U/A, transfusion
amount,ascites routine if significant ascites noted,CXR, endoscopic finding of varices;
lowest blood pressure before allocation, Child-Pugh classification of the patient
Surveillance: rebleeding and infection during admission, Transfusion amount and
hospitalization day after allocation, rebleeding rate within 14 days & mortality rate
within 28 days.

4. End points Primary end points: Rebleeding rate within 14 days after initial endoscopic
treatment. Definition of rebleeding: the following manifestation after stabilization of
vital sign for 24 hours,(1) appearance of hematemesis and bloody stool(2) need of
transfusion more than 2 units of blood and vital sign change (systolic pressure < 100
mmHg or heart rate >100 beats/min).

Secondary end points: infection during admission, mortality rate within 28 days. Definition
of infection: 1) bacteremia:positive blood culture, but no definite focus indentified, 2)
spontaneous bacterial peritonitis : ascites routine: PMN> 250/mm3, 3)urinary tract
infection: U/A WBC > 15/HPF and positive urine culture, 4)other infections: suspected by
clinical, radiological or other bacterialogical examination, 5)respiratory tract
infection:CXR changes with clinical evidence, 6)possible infection: fever (>37.5。C more than
6 hours) and leucocytosis,WBC > 15000 mm3 ,but with negative blood culture

Inclusion Criteria:

- those patients suffering from variceal bleeding documented by endoscopic examination
and without apparent evidence of infection.

Exclusion Criteria:

- received antibiotics within 2 weeks, less than 18 years old, get pregnant, have
malignancy other than HCC, have allergy to ceftrioxone

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

rebleeding rate within 14 days

Outcome Time Frame:

14 days

Safety Issue:


Principal Investigator

Tzong-Hsi Lee, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Far Eastern Memorial Hospital


Taiwan: Department of Health

Study ID:




Start Date:

March 2009

Completion Date:

September 2011

Related Keywords:

  • Esophageal and Gastric Varices
  • Gastrointestinal Hemorrhage
  • variceal bleeding
  • antibiotic prophylaxis
  • ceftrioxone
  • Esophageal and Gastric Varices
  • Esophageal Diseases
  • Gastrointestinal Hemorrhage
  • Hemorrhage
  • Varicose Veins