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

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.

Study Overview

• Status: Withdrawn
• Conditions: Variceal Hemorrhage; Haemorrhagic Shock
• Intervention / Treatment: Drug: Octreotide Injection

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Malaquin, Dr; Phone Number: (33) 322087877; Email: malaquin.stephanie@chu-amiens.fr
• Study Contact Backup: Name: Salah MATTOUG; Phone Number: (33)322088370; Email: mattoug.salah@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80000
    • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Octreotide Injection; Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of microcirculatory flow index	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.	one hour after octreotide perfusion
Change from baseline of microcirculatory flow index	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.	2 hours after octreotide perfusion
Change from baseline of microcirculatory flow index	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.	6 hours after octreotide perfusion
Change from baseline of microcirculatory flow index	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.	12 hours after octreotide perfusion
Change from baseline of microcirculatory flow index	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.	24 hours after octreotide perfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of perfused vessels	percentage of perfused vessels will be measured with sidestream dark field handheld microscope	before and one hour after octreotide perfusion
percentage of perfused vessels	percentage of perfused vessels will be measured with sidestream dark field handheld microscope	2 hours after octreotide perfusion
percentage of perfused vessels	percentage of perfused vessels will be measured with sidestream dark field handheld microscope	6 hours after octreotide perfusion
percentage of perfused vessels	percentage of perfused vessels will be measured with sidestream dark field handheld microscope	12 hours after octreotide perfusion
percentage of perfused vessels	percentage of perfused vessels will be measured with sidestream dark field handheld microscope	24 hours after octreotide perfusion
functional capillary density	functional capillary density will be measured with sidestream dark field handheld microscope	before and one hour after octreotide perfusion
functional capillary density	functional capillary density will be measured with sidestream dark field handheld microscope	2 hours after octreotide perfusion
functional capillary density	functional capillary density will be measured with sidestream dark field handheld microscope	6 hours after octreotide perfusion
functional capillary density	functional capillary density will be measured with sidestream dark field handheld microscope	12 hours after octreotide perfusion
functional capillary density	functional capillary density will be measured with sidestream dark field handheld microscope	24 hours after octreotide perfusion
Mean arterial pressure	Mean arterial pressure	before and one hour after octreotide perfusion
Mean arterial pressure	Mean arterial pressure	2 hours after octreotide perfusion
Mean arterial pressure	Mean arterial pressure	6 hours after octreotide perfusion
Mean arterial pressure	Mean arterial pressure	12 hours after octreotide perfusion
Mean arterial pressure	Mean arterial pressure	24 hours after octreotide perfusion
heart rate	heart rate	before and one hour after octreotide perfusion
heart rate	heart rate	2 hours after octreotide perfusion
heart rate	heart rate	6 hours after octreotide perfusion
heart rate	heart rate	12 hours after octreotide perfusion
heart rate	heart rate	24 hours after octreotide perfusion
ejection fraction	ejection fraction	before and one hour after octreotide perfusion
ejection fraction	ejection fraction	2 hours after octreotide perfusion
ejection fraction	ejection fraction	6 hours after octreotide perfusion
ejection fraction	ejection fraction	12 hours after octreotide perfusion
ejection fraction	ejection fraction	24 hours after octreotide perfusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: microcirculation; norepinephrine; octreotide; Variceal Hemorrhage; Haemorrhagic Shock
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Shock; Shock, Hemorrhagic; Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: PI2018_843_0016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No