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OpenTrials
Completed

NCT Number: NCT03436641

Microcirculation in Cardiogenic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nancy - Hôpital Brabois, Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. incidence of microcirculatory impairment in cardiogenic shock

    Time frame: 28 days

    evaluate the incidence of clinical parameters of involvement of microcirculation in cardiogenic shock, and their prognosis in the outcome of these patients.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Study of Microcirculation in Cardiogenic Shock

Acronym: MicroShock

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 19, 2018
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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