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

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ClinicalTrials.gov Identifier: NCT03891849
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Shock

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. percentage of perfused vessels [ Time Frame: before and one hour after octreotide perfusion ]
    percentage of perfused vessels will be measured with sidestream dark field handheld microscope

  2. percentage of perfused vessels [ Time Frame: 2 hours after octreotide perfusion ]
    percentage of perfused vessels will be measured with sidestream dark field handheld microscope

  3. percentage of perfused vessels [ Time Frame: 6 hours after octreotide perfusion ]
    percentage of perfused vessels will be measured with sidestream dark field handheld microscope

  4. percentage of perfused vessels [ Time Frame: 12 hours after octreotide perfusion ]
    percentage of perfused vessels will be measured with sidestream dark field handheld microscope

  5. percentage of perfused vessels [ Time Frame: 24 hours after octreotide perfusion ]
    percentage of perfused vessels will be measured with sidestream dark field handheld microscope

  6. functional capillary density [ Time Frame: before and one hour after octreotide perfusion ]
    functional capillary density will be measured with sidestream dark field handheld microscope

  7. functional capillary density [ Time Frame: 2 hours after octreotide perfusion ]
    functional capillary density will be measured with sidestream dark field handheld microscope

  8. functional capillary density [ Time Frame: 6 hours after octreotide perfusion ]
    functional capillary density will be measured with sidestream dark field handheld microscope

  9. functional capillary density [ Time Frame: 12 hours after octreotide perfusion ]
    functional capillary density will be measured with sidestream dark field handheld microscope

  10. functional capillary density [ Time Frame: 24 hours after octreotide perfusion ]
    functional capillary density will be measured with sidestream dark field handheld microscope

  11. Mean arterial pressure [ Time Frame: before and one hour after octreotide perfusion ]
    Mean arterial pressure

  12. Mean arterial pressure [ Time Frame: 2 hours after octreotide perfusion ]
    Mean arterial pressure

  13. Mean arterial pressure [ Time Frame: 6 hours after octreotide perfusion ]
    Mean arterial pressure

  14. Mean arterial pressure [ Time Frame: 12 hours after octreotide perfusion ]
    Mean arterial pressure

  15. Mean arterial pressure [ Time Frame: 24 hours after octreotide perfusion ]
    Mean arterial pressure

  16. heart rate [ Time Frame: before and one hour after octreotide perfusion ]
    heart rate

  17. heart rate [ Time Frame: 2 hours after octreotide perfusion ]
    heart rate

  18. heart rate [ Time Frame: 6 hours after octreotide perfusion ]
    heart rate

  19. heart rate [ Time Frame: 12 hours after octreotide perfusion ]
    heart rate

  20. heart rate [ Time Frame: 24 hours after octreotide perfusion ]
    heart rate

  21. ejection fraction [ Time Frame: before and one hour after octreotide perfusion ]
    ejection fraction

  22. ejection fraction [ Time Frame: 2 hours after octreotide perfusion ]
    ejection fraction

  23. ejection fraction [ Time Frame: 6 hours after octreotide perfusion ]
    ejection fraction

  24. ejection fraction [ Time Frame: 12 hours after octreotide perfusion ]
    ejection fraction

  25. ejection fraction [ Time Frame: 24 hours after octreotide perfusion ]
    ejection fraction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891849


Contacts
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Contact: Stéphanie Malaquin, Dr (33) 322087877 malaquin.stephanie@chu-amiens.fr
Contact: Salah MATTOUG (33)322088370 mattoug.salah@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, France, 80000
Contact: Stephanie MALAQUIN, MD       malaquin.stephanie@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Stéphanie Malaquin, Dr CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03891849    
Other Study ID Numbers: PI2018_843_0016
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
microcirculation
octreotide
norepinephrine
Variceal Hemorrhage
Haemorrhagic Shock
Additional relevant MeSH terms:
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Hemorrhage
Shock
Shock, Hemorrhagic
Pathologic Processes
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents