Bleeding, Esophageal and Gastric Varices, Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage
Conditions
Brief summary
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.
Detailed description
Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.
Interventions
DRUGTerlipressin
According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of liver cirrhosis; 2. Child-Pugh B or C; 3. Acute gastroesophageal variceal bleeding; 4. Written informed consents. -
Exclusion criteria
1. No liver cirrhosis; 2. Child-Pugh class A; 3. Acute upper gastrointestinal bleeding unrelated to varices; 4. Use of somatostatin or octreotide. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 day treatment failure | 5 days (120 hours) | Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six-week mortality | 6 weeks | Death with 6 weeks after treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to terlipressin [Safety] | 5 days after treatment | Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc. |
Contacts
Primary ContactXingshun Qi, MD
Backup ContactXiaozhong Guo, MD
Outcome results
None listed