Clinical trial

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

ID

Name

PI2018_843_0016

Description

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.

Trial arms

Trial start

2021-09-01

Estimated PCD

2023-05-01

Trial end

2023-05-01

Status

Withdrawn

Treatment

Octreotide Injection

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

Arms:

octreotide (25 µg/hour) perfusion

Primary endpoint

Change from baseline of microcirculatory flow index

one hour after octreotide perfusion

Change from baseline of microcirculatory flow index

2 hours after octreotide perfusion

Change from baseline of microcirculatory flow index

6 hours after octreotide perfusion

Change from baseline of microcirculatory flow index

12 hours after octreotide perfusion

Change from baseline of microcirculatory flow index

24 hours after octreotide perfusion

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-02-09

1 organization

1 product

2 indications

Organization

Centre Hospitalier Universitaire Amiens

Product

Indication

Hemorrhagic Shock

Indication

Variceal Hemorrhage