Clinical trial NCT03891849: Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Haemorrhagic Shock
Variceal Hemorrhage
Keywords: microcirculation
octreotide
norepinephrine
Variceal Hemorrhage
Haemorrhagic Shock
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline of microcirculatory flow index
timeFrame: one hour after octreotide perfusion
measure: Change from baseline of microcirculatory flow index
timeFrame: 2 hours after octreotide perfusion
measure: Change from baseline of microcirculatory flow index
timeFrame: 6 hours after octreotide perfusion
measure: Change from baseline of microcirculatory flow index
timeFrame: 12 hours after octreotide perfusion
measure: Change from baseline of microcirculatory flow index
timeFrame: 24 hours after octreotide perfusion
Secondary outcomes:
measure: percentage of perfused vessels
timeFrame: before and one hour after octreotide perfusion
measure: percentage of perfused vessels
timeFrame: 2 hours after octreotide perfusion
measure: percentage of perfused vessels
timeFrame: 6 hours after octreotide perfusion
measure: percentage of perfused vessels
timeFrame: 12 hours after octreotide perfusion
measure: percentage of perfused vessels
timeFrame: 24 hours after octreotide perfusion
measure: functional capillary density
timeFrame: before and one hour after octreotide perfusion
measure: functional capillary density
timeFrame: 2 hours after octreotide perfusion
measure: functional capillary density
timeFrame: 6 hours after octreotide perfusion
measure: functional capillary density
timeFrame: 12 hours after octreotide perfusion
measure: functional capillary density
timeFrame: 24 hours after octreotide perfusion
measure: Mean arterial pressure
timeFrame: before and one hour after octreotide perfusion
measure: Mean arterial pressure
timeFrame: 2 hours after octreotide perfusion
measure: Mean arterial pressure
timeFrame: 6 hours after octreotide perfusion
measure: Mean arterial pressure
timeFrame: 12 hours after octreotide perfusion
measure: Mean arterial pressure
timeFrame: 24 hours after octreotide perfusion
measure: heart rate
timeFrame: before and one hour after octreotide perfusion
measure: heart rate
timeFrame: 2 hours after octreotide perfusion
measure: heart rate
timeFrame: 6 hours after octreotide perfusion
measure: heart rate
timeFrame: 12 hours after octreotide perfusion
measure: heart rate
timeFrame: 24 hours after octreotide perfusion
measure: ejection fraction
timeFrame: before and one hour after octreotide perfusion
measure: ejection fraction
timeFrame: 2 hours after octreotide perfusion
measure: ejection fraction
timeFrame: 6 hours after octreotide perfusion
measure: ejection fraction
timeFrame: 12 hours after octreotide perfusion
measure: ejection fraction
timeFrame: 24 hours after octreotide perfusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Stéphanie Malaquin, Dr
role: PRINCIPAL_INVESTIGATOR
References: