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No participant enrolled. Equipment unvailable.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| octreotide (25 µg/hour) perfusion | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Injection | Drug | Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphanie Malaquin, Dr | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Amiens | 80000 | France |
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| 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 |
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 |
| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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