MicroShock: Microcirculation in Cardiogenic Shock

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03436641
Collaborator
(none)
100
2
40.2
50
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Microcirculation in Cardiogenic Shock
Actual Study Start Date :
Oct 25, 2018
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. incidence of microcirculatory impairment in cardiogenic shock [28 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nancy - Hôpital Brabois Nancy France 54511
2 Les Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Hamid MERDJI, Les Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03436641
Other Study ID Numbers:
  • 6951
First Posted:
Feb 19, 2018
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022