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Clinical Trials/NCT04173221
NCT04173221
Completed
N/A

Direct Assessment of Microcirculation In Shock (DAMIS)

Heinrich-Heine University, Duesseldorf5 sites in 1 country141 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Microcirculation
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
141
Locations
5
Primary Endpoint
mortality
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Maintaining organ perfusion is the key to successful intensive care medicine. Shock is the most dangerous microcirculatory disorder and one of the most hazardous and lethal conditions of critically ill patients still showing high mortality rates. However, there are still ongoing controversies, how to assess microcirculation, how to predict outcome in time and how to guide specific therapy. Macrocirculation does not reflect microcirculation. Microcirculation reflects organ perfusion and correlates with the outcome. There is growing evidence that microcirculatory parameters are powerful tools to predict the outcome after cardiac arrest. Several guidelines use it as a target to guide therapy, but these recommendations base only on supporting evidence of low quality. Lactate is a late reflector of reduced organ perfusion and is of limited value for time-critical decision-making and their value as a therapeutic target. Sublingual sidestream dark-field (SDF) - measurement is a non-invasive method that reliably reflects organ perfusion. The last generation of microcirculation assessment tools are easy to use hand-held devices that use an automatic algorithm. In consequence, microcirculation has become a directly detectable physiological compartment. However, systematic investigations about this technology in shock are still lacking. DAMIS determines the value of directly assessed microcirculation on outcome in different types of shock. Therefore, this multicenter study will recruit up to 200 patients in shock. After the first measurement, patients will be randomized either to intervention or to control. The intervention consists in knowing microcirculatory parameters. A checklist will assist the treating physicians of the interventional group in explaining microcirculatory values and offering possible treatment options. Patients in the control group will be measured as well, but results will not be communicated to the treating physician.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
August 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Older than 18 years
  • Admitted to the ICU in state of shock at the time point of admission to ICU or in the first 3 hours defined as
  • the need to use vasopressors, -dilatators, fluids to maintain mean arterial pressure \> 65 mmHg
  • AND lactate \> 2 mmol/l

Exclusion Criteria

  • Younger than 18 years
  • Anatomic reasons that inhibit sublingual measurement
  • Lack of informed consent
  • more than 4 hours after ICU admission

Outcomes

Primary Outcomes

mortality

Time Frame: 30 day

relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality

Secondary Outcomes

  • length of stay at ICU and hospital(90 days)
  • mortality(6 and 12 months)

Study Sites (5)

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