Status:
UNKNOWN
2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Control Acute Gastroesophageal Variceal Hemorrhage
Lead Sponsor:
E-DA Hospital
Conditions:
Variceal Rebleeding Rate and Infections
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 c...
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 endosc...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04056806
Start Date
August 1 2019
End Date
August 1 2022
Last Update
August 14 2019
Active Locations (1)
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1
E-Da Hospital
Kaohsiung City, Taiwan, 824