Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

NCT03130127 — Not applicable, Unknown, 40 participants, General Hospital of Shenyang Military Region

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Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial

Registry	NCT03130127
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	General Hospital of Shenyang Military Region (Other)
Conditions	Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage, Bleeding, Esophageal and Gastric Varices
Interventions	Terlipressin (Drug)
Dates	start 2024-07-01 (estimated), primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2017-04-26, last updated 2024-02-23

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Continuous infusion of terlipressin	Experimental	Drug: Terlipressin	In our clinical practice, continuous infusion of terlipressin is being employed.
Bolus infusion of terlipressin	Active comparator	Drug: Terlipressin	Traditionally, a bolus infusion of terlipressin is recommended.

Terlipressin (Drug), also known as Glypressin: According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.

+Outcome measures

Primary outcomes

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 outcomes

Six-week mortality [6 weeks]: Death with 6 weeks after treatment

Other outcomes

Adverse events related to terlipressin [Safety] [5 days after treatment]: Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.

+Eligibility

Sex: All

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. -

+Investigators

Xiaozhong Guo, MD, Principal investigator, General Hospital of Shenyang Military Area

My Notes

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