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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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.

Overall Status Recruiting
Start Date July 2020
Completion Date April 2022
Primary Completion Date April 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline of microcirculatory flow index one hour after octreotide perfusion
Change from baseline of microcirculatory flow index 2 hours after octreotide perfusion
Change from baseline of microcirculatory flow index 6 hours after octreotide perfusion
Change from baseline of microcirculatory flow index 12 hours after octreotide perfusion
Change from baseline of microcirculatory flow index 24 hours after octreotide perfusion
Secondary Outcome
Measure Time Frame
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
functional capillary density before and one hour after octreotide perfusion
functional capillary density 2 hours after octreotide perfusion
functional capillary density 6 hours after octreotide perfusion
functional capillary density 12 hours after octreotide perfusion
functional capillary density 24 hours after octreotide perfusion
Mean arterial pressure before and one hour after octreotide perfusion
Mean arterial pressure 2 hours after octreotide perfusion
Mean arterial pressure 6 hours after octreotide perfusion
Mean arterial pressure 12 hours after octreotide perfusion
Mean arterial pressure 24 hours after octreotide perfusion
heart rate before and one hour after octreotide perfusion
heart rate 2 hours after octreotide perfusion
heart rate 6 hours after octreotide perfusion
heart rate 12 hours after octreotide perfusion
heart rate 24 hours after octreotide perfusion
ejection fraction before and one hour after octreotide perfusion
ejection fraction 2 hours after octreotide perfusion
ejection fraction 6 hours after octreotide perfusion
ejection fraction 12 hours after octreotide perfusion
ejection fraction 24 hours after octreotide perfusion
Enrollment 32
Condition
Intervention

Intervention Type: Drug

Intervention Name: Octreotide Injection

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

Arm Group Label: octreotide (25 µg/hour) perfusion

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stéphanie Malaquin, Dr Principal Investigator CHU Amiens
Overall Contact

Last Name: Stéphanie Malaquin, Dr

Phone: (33) 322087877

Email: [email protected]

Location
Facility: Status: Contact: CHU Amiens Picardie Stephanie MALAQUIN, MD [email protected]
Location Countries

France

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: octreotide (25 µg/hour) perfusion

Type: Experimental

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

Acronym HemodyNoOc
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov