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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT03891849

Collaborator

(none)

Enrollment

Location

Arm

19.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Haemorrhagic Shock Variceal Hemorrhage	Drug: Octreotide Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of microcirculatory flow index [one hour 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.
Change from baseline of microcirculatory flow index [2 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.
Change from baseline of microcirculatory flow index [6 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.
Change from baseline of microcirculatory flow index [12 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.
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

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