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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous infusion of terlipressin | Experimental | In our clinical practice, continuous infusion of terlipressin is being employed. |
|
| Bolus infusion of terlipressin | Active Comparator | Traditionally, a bolus infusion of terlipressin is recommended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5 day treatment failure | 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. | 5 days (120 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Six-week mortality | Death with 6 weeks after treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to terlipressin [Safety] | Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc. | 5 days after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi, MD | Contact | 86-18909881019 | xingshunqi@126.com | |
| Xiaozhong Guo, MD | Contact | 86-024-28897613 | guo_xiao_zhong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaozhong Guo, MD | General Hospital of Shenyang Military Area | Principal Investigator |
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|
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D006470 | Hemorrhage |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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