Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock

NCT ID: NCT03891849

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-05-31

Brief Summary

Octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. When patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. Microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. The aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.

Conditions

Haemorrhagic Shock; Variceal Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

octreotide (25 µg/hour) perfusion

octreotide (25 µg/hour) plus norepinephrine will be administered for patient with haemorrhagic shock after variceal bleeding during 2 to 5 days according recommendations and regular protocol in the medical unit

Group Type: EXPERIMENTAL

Octreotide Injection

Intervention Type: DRUG

Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.

Interventions

Octreotide Injection

Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients more than 18 years old
• patient with liver cirrhosis
• patient with haemorrhagic shock due to variceal bleeding
• patient with an arterial blood pressure less than 65 mmHg despite
• patient able to express consent
• signed written informed consent form
• patient covered by national health insurance

Exclusion Criteria

• patient less than 18 years old
• patient non covered by national health insurance
• pregnant or breast feeding patent
• known octreotide allergy
• cardiac arrest because of shock
• refused consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Malaquin, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens Picardie

Amiens, , France

Countries

France

Other Identifiers

PI2018_843_0016

Identifier Type: -

Identifier Source: org_study_id