Esophageal and Gastric Varices, Hemorrhage, Liver Cirrhosis
Conditions
Keywords
acute variceal hemorrhage, terlipressin, somatostatin, octreotide, comparative effectiveness research
Brief summary
To observe and access the Effects and safety of terlipressin or high dose somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in patients with acute variceal bleeding.
Detailed description
The prognosis information of the patients with acute variceal bleeding will be collected, including hemostasis rate, early rebleeding rate, mortality, complications, severity adverse events, economic burdens and quality of life, when terlipressin or high dose somatostatin/octreotide is used as salvation to patients fail to achieve initial hemostasis.The results may help gastroenterologists to make decisions when administering vasoactive medicines to those suffered from acute variceal bleeding.
Interventions
DRUGTerlipressin
administered as a first-line medicine or as salvage
DRUGUsual Dose Somatostatin/Octreotide
administered as a first-line medicine or as salvage
DRUGHigh Dose Somatostatin/Octreotide
administered as salvage
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding
Exclusion criteria
* No signs of variceal bleeding are found by endoscopy or portal hypertensive gastropathy is responsible for the bleeding * Patients undergo endoscopy after 72h from the beginning of acute variceal bleeding * Patients with hepatorenal syndrome * Patients with ischemia organic cardiopathy (including myocardial infarction or unstable angina pectoris) or myocardial ischemia indicated by ECG in the past 6 months * Patients allergic to/with contraindications of vasoactive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Change of Rebleeding Rate | 1month, 3months, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Economic Cost | up to 12 months |
| The Change of Quality of Life | 1month, 3months, 6 months, 12 months |
| The Change of Survival Rate | 1month, 3months, 6 months, 12 months |
| The Change of Complication Rate | 1month, 3months, 6 months, 12 months |
| The Change of Drug Adverse Reaction Rate | 1month, 3months, 6 months, 12 months |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed