Clinical trial NCT03436641: Microcirculation in Cardiogenic Shock
Official title: Study of Microcirculation in Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Standard management of cardiogenic shock

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of microcirculatory impairment in cardiogenic shock
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Hamid MERDJI
role: PRINCIPAL_INVESTIGATOR
References: