Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails (CER:T)

Fudan University

Status

Unknown

Conditions

Hemorrhage

Liver Cirrhosis

Esophageal and Gastric Varices

Treatments

Drug: High Dose Somatostatin/Octreotide

Drug: Terlipressin

Drug: Usual Dose Somatostatin/Octreotide

Study type

Observational

Funder types

Other

Identifiers

NCT02311608

CSY-LB2-2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,320 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

1,320 participants in 5 patient groups

High Dose Somatostatin/Octreotide

Description:

continuous IV infusion of 500μg/h of Somatostatin or continuous IV infusion of 50μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients

Treatment:

Drug: Usual Dose Somatostatin/Octreotide

Drug: High Dose Somatostatin/Octreotide

Terlipressin as salvage

Description:

an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients

Treatment:

Drug: Usual Dose Somatostatin/Octreotide

Drug: Terlipressin

Terlipr+usual dose somato/Octreo

Description:

an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h together with continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide when usual somatostatin or Octreotide dose fails to achieve hemostasis of acute variceal bleeding patients

Treatment:

Drug: Usual Dose Somatostatin/Octreotide

Drug: Terlipressin

Drug: High Dose Somatostatin/Octreotide

Control:Usual Dose Somato/Octreo

Description:

Hemostasis achieved by continuous IV infusion of 250μg/h of Somatostatin or continuous IV infusion of 25μg/h of Octreotide

Treatment:

Drug: Usual Dose Somatostatin/Octreotide

Control: Initial Terlipressin

Description:

Hemostasis achieved by an initial injection of 2mg of Terlipressin followed by an injection of 1mg of Terlipressin per 6h