Haemorrhagic ShockHemodyNoOcNCT03891849
Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
A study testing Octreotide Injection in people with Haemorrhagic Shock and Variceal Hemorrhage, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhagic Shock, Variceal Hemorrhage
- What is being tested?
- Octreotide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Haemorrhagic Shock, Variceal Hemorrhage
- Being tested
- Octreotide Injection
- Keywords
- microcirculation, octreotide, norepinephrine, Variceal Hemorrhage, Haemorrhagic Shock
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide InjectionDrug
Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Octreotide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours after octreotide perfusion
Secondary outcomes (25)
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Measured: before and one hour after octreotide perfusion
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Measured: 2 hours after octreotide perfusion
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Measured: 6 hours after octreotide perfusion
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Measured: 12 hours after octreotide perfusion
percentage of perfused vessels
percentage of perfused vessels will be measured with sidestream dark field handheld microscope
Measured: 24 hours after octreotide perfusion
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Measured: before and one hour after octreotide perfusion
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Measured: 2 hours after octreotide perfusion
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Measured: 6 hours after octreotide perfusion
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Measured: 12 hours after octreotide perfusion
functional capillary density
functional capillary density will be measured with sidestream dark field handheld microscope
Measured: 24 hours after octreotide perfusion
Mean arterial pressure
Mean arterial pressure
Measured: before and one hour after octreotide perfusion
Mean arterial pressure
Mean arterial pressure
Measured: 2 hours after octreotide perfusion
Mean arterial pressure
Mean arterial pressure
Measured: 6 hours after octreotide perfusion
Mean arterial pressure
Mean arterial pressure
Measured: 12 hours after octreotide perfusion
Mean arterial pressure
Mean arterial pressure
Measured: 24 hours after octreotide perfusion
heart rate
heart rate
Measured: before and one hour after octreotide perfusion
heart rate
heart rate
Measured: 2 hours after octreotide perfusion
heart rate
heart rate
Measured: 6 hours after octreotide perfusion
heart rate
heart rate
Measured: 12 hours after octreotide perfusion
heart rate
heart rate
Measured: 24 hours after octreotide perfusion
ejection fraction
ejection fraction
Measured: before and one hour after octreotide perfusion
ejection fraction
ejection fraction
Measured: 2 hours after octreotide perfusion
ejection fraction
ejection fraction
Measured: 6 hours after octreotide perfusion
ejection fraction
ejection fraction
Measured: 12 hours after octreotide perfusion
ejection fraction
ejection fraction
Measured: 24 hours after octreotide perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: No participant enrolled. Equipment unvailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Malaquin, Dr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891849
- Sponsor's protocol ID
- PI2018_843_0016
- Acronym
- HemodyNoOc
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT03891849
- Acronym / sponsor ID
- HemodyNoOc / PI2018_843_0016
- Conditions
- Haemorrhagic Shock, Variceal Hemorrhage
- Keywords
- microcirculation, octreotide, norepinephrine, Variceal Hemorrhage, Haemorrhagic Shock
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant enrolled. Equipment unvailable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| octreotide (25 µg/hour) perfusion | Experimental | Drug: Octreotide Injectionoctreotide (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide InjectionPatients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour. | Drug | octreotide (25 µg/hour) perfusion |
Primary outcome
Change from baseline of microcirculatory flow index
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
25 secondary outcomes
percentage of perfused vessels
Time frame: before and one hour after octreotide perfusion
percentage of perfused vessels
Time frame: 2 hours after octreotide perfusion
percentage of perfused vessels
Time frame: 6 hours after octreotide perfusion
percentage of perfused vessels
Time frame: 12 hours after octreotide perfusion
percentage of perfused vessels
Time frame: 24 hours after octreotide perfusion
functional capillary density
Time frame: before and one hour after octreotide perfusion
functional capillary density
Time frame: 2 hours after octreotide perfusion
functional capillary density
Time frame: 6 hours after octreotide perfusion
functional capillary density
Time frame: 12 hours after octreotide perfusion
functional capillary density
Time frame: 24 hours after octreotide perfusion
Mean arterial pressure
Time frame: before and one hour after octreotide perfusion
Mean arterial pressure
Time frame: 2 hours after octreotide perfusion
Mean arterial pressure
Time frame: 6 hours after octreotide perfusion
Mean arterial pressure
Time frame: 12 hours after octreotide perfusion
Mean arterial pressure
Time frame: 24 hours after octreotide perfusion
heart rate
Time frame: before and one hour after octreotide perfusion
heart rate
Time frame: 2 hours after octreotide perfusion
heart rate
Time frame: 6 hours after octreotide perfusion
heart rate
Time frame: 12 hours after octreotide perfusion
heart rate
Time frame: 24 hours after octreotide perfusion
ejection fraction
Time frame: before and one hour after octreotide perfusion
ejection fraction
Time frame: 2 hours after octreotide perfusion
ejection fraction
Time frame: 6 hours after octreotide perfusion
ejection fraction
Time frame: 12 hours after octreotide perfusion
ejection fraction
Time frame: 24 hours after octreotide perfusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Malaquin, Dr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octreotide Injection in people with Haemorrhagic Shock and Variceal Hemorrhage, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of microcirculatory flow index (time frame: one hour after octreotide perfusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.