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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03891849
Acronym
HemodyNoOc
Enrollment
0
Registered
2019-03-27
Start date
2021-09-01
Completion date
2023-05-31
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemorrhagic Shock, Variceal Hemorrhage

Keywords

microcirculation, octreotide, norepinephrine, Variceal Hemorrhage, Haemorrhagic Shock

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.

Interventions

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of microcirculatory flow indexone hour after octreotide perfusionmicrocirculatory 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

MeasureTime frameDescription
heart ratebefore and one hour after octreotide perfusionheart rate
percentage of perfused vesselsbefore and one hour after octreotide perfusionpercentage of perfused vessels will be measured with sidestream dark field handheld microscope
functional capillary densitybefore and one hour after octreotide perfusionfunctional capillary density will be measured with sidestream dark field handheld microscope
Mean arterial pressurebefore and one hour after octreotide perfusionMean arterial pressure
ejection fractionbefore and one hour after octreotide perfusionejection fraction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026