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

Variceal Hemorrhage Clinical Trial

— HemodyNoOc  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03891849
• Other study ID #: PI2018_843_0016
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemorrhagic Shock
• Hemorrhage
• Shock
• Shock, Hemorrhagic
• Variceal Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

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