Direct Assessment of Microcirculation In Shock (DAMIS)

Not Applicable

Completed

• Conditions: Intensive Care; Shock; Microcirculation
• Interventions: Other: Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician; Other: Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician

• Registration Number: NCT04173221
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-02-01
• Primary Completion: 2022-08-27
• Study Completion: 2022-08-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician	-
Control	Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician	-

Primary Outcome Measures

Name	Time	Method
mortality	30 day	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality

Secondary Outcome Measures

Name	Time	Method
length of stay at ICU and hospital	90 days	relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay
mortality	6 and 12 months	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality

Trial Locations

Locations (5)

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, Germany