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

Not Applicable

Withdrawn

• Conditions: Variceal Hemorrhage; Haemorrhagic Shock
• Interventions: Drug: Octreotide Injection

• Registration Number: NCT03891849
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2021-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
octreotide (25 µg/hour) perfusion	Octreotide Injection	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

Primary Outcome Measures

Name	Time	Method
Change from baseline of microcirculatory flow index	24 hours after octreotide perfusion	microcirculatory flow index will be measured with sidestream dark field handheld microscope. Baseline is before octreotide perfusion. Flow characteristics of the microvasculature will be quantified using the microcirculatory flow index (MFI) according to the recommendations from the consensus on microcirculatory imaging by De Backer et al. This index will be calculated after the image will be divided into four quadrants, and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, abnormal = 3, and hyperdynamic = 4) would be estimated in the vessels smaller than 25 μm by the operator. The final MFI score is a value obtained from the average score of the four areas.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	24 hours after octreotide perfusion	Mean arterial pressure
ejection fraction	24 hours after octreotide perfusion	ejection fraction
functional capillary density	24 hours after octreotide perfusion	functional capillary density will be measured with sidestream dark field handheld microscope
heart rate	24 hours after octreotide perfusion	heart rate
percentage of perfused vessels	24 hours after octreotide perfusion	percentage of perfused vessels will be measured with sidestream dark field handheld microscope

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France