Back to resultsMacro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock (HemodyNoOc)
Primary Purpose
Haemorrhagic Shock, Variceal Hemorrhage
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Octreotide Injection
Sponsored by
About this trial
This is an interventional treatment trial for Haemorrhagic Shock focused on measuring microcirculation, octreotide, norepinephrine, Variceal Hemorrhage, Haemorrhagic Shock
Eligibility Criteria
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
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
octreotide (25 µg/hour) perfusion
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
heart rate
heart rate
heart rate
heart rate
heart rate
heart rate
heart rate
heart rate
heart rate
heart rate
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
ejection fraction
Full Information
NCT ID
NCT03891849
First Posted
March 22, 2019
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03891849
Brief Title
Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
Acronym
HemodyNoOc
Official Title
Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participant enrolled. Equipment unvailable.
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemorrhagic Shock, Variceal Hemorrhage
Keywords
microcirculation, octreotide, norepinephrine, Variceal Hemorrhage, Haemorrhagic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
octreotide (25 µg/hour) perfusion
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Octreotide Injection
Intervention Description
Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.
Primary Outcome Measure Information:
Title
Change from baseline of microcirculatory flow index
Description
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.
Time Frame
one hour after octreotide perfusion
Title
Change from baseline of microcirculatory flow index
Description
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.
Time Frame
2 hours after octreotide perfusion
Title
Change from baseline of microcirculatory flow index
Description
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.
Time Frame
6 hours after octreotide perfusion
Title
Change from baseline of microcirculatory flow index
Description
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.
Time Frame
12 hours after octreotide perfusion
Title
Change from baseline of microcirculatory flow index
Description
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.
Time Frame
24 hours after octreotide perfusion
Secondary Outcome Measure Information:
Title
percentage of perfused vessels
Description
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Time Frame
before and one hour after octreotide perfusion
Title
percentage of perfused vessels
Description
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Time Frame
2 hours after octreotide perfusion
Title
percentage of perfused vessels
Description
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Time Frame
6 hours after octreotide perfusion
Title
percentage of perfused vessels
Description
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Time Frame
12 hours after octreotide perfusion
Title
percentage of perfused vessels
Description
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Time Frame
24 hours after octreotide perfusion
Title
functional capillary density
Description
functional capillary density will be measured with sidestream dark field handheld microscope
Time Frame
before and one hour after octreotide perfusion
Title
functional capillary density
Description
functional capillary density will be measured with sidestream dark field handheld microscope
Time Frame
2 hours after octreotide perfusion
Title
functional capillary density
Description
functional capillary density will be measured with sidestream dark field handheld microscope
Time Frame
6 hours after octreotide perfusion
Title
functional capillary density
Description
functional capillary density will be measured with sidestream dark field handheld microscope
Time Frame
12 hours after octreotide perfusion
Title
functional capillary density
Description
functional capillary density will be measured with sidestream dark field handheld microscope
Time Frame
24 hours after octreotide perfusion
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
before and one hour after octreotide perfusion
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
2 hours after octreotide perfusion
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
6 hours after octreotide perfusion
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
12 hours after octreotide perfusion
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
24 hours after octreotide perfusion
Title
heart rate
Description
heart rate
Time Frame
before and one hour after octreotide perfusion
Title
heart rate
Description
heart rate
Time Frame
2 hours after octreotide perfusion
Title
heart rate
Description
heart rate
Time Frame
6 hours after octreotide perfusion
Title
heart rate
Description
heart rate
Time Frame
12 hours after octreotide perfusion
Title
heart rate
Description
heart rate
Time Frame
24 hours after octreotide perfusion
Title
ejection fraction
Description
ejection fraction
Time Frame
before and one hour after octreotide perfusion
Title
ejection fraction
Description
ejection fraction
Time Frame
2 hours after octreotide perfusion
Title
ejection fraction
Description
ejection fraction
Time Frame
6 hours after octreotide perfusion
Title
ejection fraction
Description
ejection fraction
Time Frame
12 hours after octreotide perfusion
Title
ejection fraction
Description
ejection fraction
Time Frame
24 hours after octreotide perfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Malaquin, Dr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
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