Variceal Rebleeding Rate and Infections Clinical Trial
Official title:
A Prospective, Randomized Controlled Trial of 2- Day vs. 5- Day Terlipressin and Ceftriaxone in the Prevention of Very Early Rebleeding in Patients With Acute Gastroesophageal Variceal Hemorrhage
NCT number | NCT04056806 |
Other study ID # | EMRP39107N |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 2019 |
Est. completion date | August 2022 |
Verified date | August 2019 |
Source | E-DA Hospital |
Contact | Gin-Ho Lo, M.D. |
Phone | 975-106-200 |
ghlo[@]kimo.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 could have superior acute hemostatic rate.
Thus, the investigators conducted a trial to compare the effectiveness between participants
receiving terlipressin and ceftriaxone 5 days and terlipressin and ceftriaxone 2 days after
endoscopic therapy in cirrhotic patients presenting with acute gastro-esophageal variceal
hemorrhage..
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients were diagnosed to have cirrhosis based on history, physical examinations, image studies or histological examination.. 2. Age ranges between 20-80 y/o. 3. Patients presenting with hematemesis and /or melena within 24 hours of inclusion. 4. Esophageal variceal bleeding is controlled by esophageal variceal ligation (EVL). Gastric variceal bleeding is controlled by endoscopic glue ( histoacryl) injection. - Exclusion Criteria: 1. Uncertain of bleeding source. 2. Failure in endoscopic therapy. 3. Had variceal bleeding or peptic ulcer bleeding in recent one month 4. 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 - |
Country | Name | City | State |
---|---|---|---|
Taiwan | E-Da Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
E-DA Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of very early rebleeding | The occurrence of variceal rebleeding after initial hemostasis | 5 days | |
Secondary | Bacterial infections, 42-day rebleeding, mortality | Incidence of bacterial infections & rebleeding, mortality in 6 weeks | 6 weeks |