Microcirculation in Cardiogenic Shock

Cardiogenic Shock Clinical Trial

— MicroShock  

Official title:

Study of Microcirculation in Cardiogenic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436641
• Other study ID #: 6951
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiogenic shock is usually defined as primary cardiac dysfunction with low cardiac output leading to critical organ hypo perfusion and tissue hypoxia. Despite progress in the management of cardiogenic shock, mortality remains unacceptably high. This significant mortality, close to 40 %, is partly due to profound alterations of microcirculatory blood flow in cardiogenic shock, leading to multi organ failure, despite restoration of macro-hemodynamic parameters such as blood pressure and cardiac output. The microcirculation is the terminal vascular network of the systemic circulation consisting of microvessels with diameters < 20 μm including arterioles, capillaries, and venules. This part of the circulation is critical as it is responsible for nutrient delivering and oxygen transfer from the erythrocytes in the capillaries to the parenchymal cells to meet their metabolic demands, but it is also the area where water, other gases, hormones and waste products are exchanged. Hence, the evaluation of clinical signs of peripheral hypoperfusion reflecting microvascular perfusion is of interest. We aimed to study these parameters such as skin capillary refill time (CRT), mottling and central-to-toe temperature difference (ΔTc-p) in a cardiogenic shock population. Assessing the prognosis of these microcirculation parameters and their interaction with macrocirculation parameters such as arterial pressure, cardiac index, left ventricular ejection fraction is also the aim of this study. Lastly, looking at the prognostic value of these markers seems interesting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 30, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• major patient (=18 years old)
• Patient with a cardiogenic shock table defined by the association of low cardiac output even though the filling pressures are normal or high, causing hypoperfusion and organ pain
• patient affiliated to a social security scheme
• patient (or family member / trusted or close) who has agreed to participate in the study

Exclusion Criteria:

• refusal of the patient to participate in the study
• patients with dark skin preventing the evaluation of clinical markers of microcirculation.
• subject under the protection of justice
• subject under guardianship or curatorship

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	CHU Nancy - Hôpital Brabois	Nancy
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of microcirculatory impairment in cardiogenic shock	evaluate the incidence of clinical parameters of involvement of microcirculation in cardiogenic shock, and their prognosis in the outcome of these patients.	28 days