NCT03891849

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

March 22, 2019

Last Update Submit

February 7, 2023

Conditions

Haemorrhagic ShockVariceal Hemorrhage

Keywords

microcirculationoctreotidenorepinephrineVariceal HemorrhageHaemorrhagic Shock

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

Secondary Outcomes (25)

  • percentage of perfused vessels

    before and one hour after octreotide perfusion

  • percentage of perfused vessels

    2 hours after octreotide perfusion

  • percentage of perfused vessels

    6 hours after octreotide perfusion

  • percentage of perfused vessels

    12 hours after octreotide perfusion

  • percentage of perfused vessels

    24 hours after octreotide perfusion

  • +20 more secondary outcomes

Study Arms (1)

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

Drug: Octreotide Injection

Interventions

Octreotide InjectionDRUG

Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.

octreotide (25 µg/hour) perfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, 80000, France

Location

MeSH Terms

Conditions

Shock, Hemorrhagic

Interventions

Octreotide

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Stéphanie Malaquin, Dr

    CHU Amiens

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 27, 2019

Study Start

September 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)