Clinical trial NCT04173221: Direct Assessment of Microcirculation In Shock (DAMIS)
Official title: Direct Assessment of Microcirculation In Shock (DAMIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcirculation
Intensive Care
Shock
Keywords: Microcirculation
Intensive Care
Critical care
shock
risk stratification
SDF-measurement
fluid resuscitation
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Older than 18 years
2. 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:

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

Primary outcomes:
measure: mortality
timeFrame: 30 day
Secondary outcomes:
measure: mortality
timeFrame: 6 and 12 months
measure: length of stay at ICU and hospital
timeFrame: 90 days
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
city: Freiburg im Breisgau
country: Germany
facility: Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Department of Cardiology, Heart Center Leipzig at University of Leipzig
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine
Study officials:
References: