Direct Assessment of Microcirculation In Shock (DAMIS)

Shock Clinical Trial

Official title:

Direct Assessment of Microcirculation In Shock (DAMIS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173221
• Other study ID #: DAMIS
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 30, 2022
• Est. primary completion date: August 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care
• Microcirculation
• Shock

Intervention

Other:
• Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician
Sublingual SDF-Measurement at admission and after 24h, with communication and interpreting checklist to the treating physician
• Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician
Sublingual SDF-Measurement at admission and after 24h, without communication and interpreting checklist to the treating physician

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Duesseldorf
Germany	Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine	Freiburg im Breisgau
Germany	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Department of Cardiology, Heart Center Leipzig at University of Leipzig	Leipzig
Germany	Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality	30 day
Secondary	mortality	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality	6 and 12 months
Secondary	length of stay at ICU and hospital	relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay	90 days