CClinicalTrials.gg
CompletedNCT03436641MicroShockUpdated Aug 23, 2023

Microcirculation in Cardiogenic Shock

An observational study in Cardiogenic Shock, sponsored by University Hospital, Strasbourg, France. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiogenic Shock
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Standard management of cardiogenic shock

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days

06

Study locations

2 sites
  • CHU Nancy - Hôpital Brabois
    Nancy, 54511, France
  • Les Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03436641
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Sep 1, 2018
Primary completion
Sep 1, 2018
Completion
Jul 30, 2020
Last update
Aug 23, 2023

Study contacts

Hamid MERDJI
principal investigator · Les Hôpitaux Universitaires de Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion