Direct Assessment of Microcirculation In Shock (DAMIS)

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.

Study Overview

• Status: Completed
• Conditions: Shock; Intensive Care; Microcirculation
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Jung, MD; Phone Number: +2118118800; Email: ctu@med.uni-duesseldorf.de
• Study Contact Backup: Name: Raphael Bruno, MD; Phone Number: +2118118800; Email: ctu@med.uni-duesseldorf.de

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine
  • Freiburg im Breisgau, Germany
    • Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine
  • Hamburg, Germany
    • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
  • Leipzig, Germany
    • Department of Cardiology, Heart Center Leipzig at University of Leipzig
  • Stuttgart, Germany
    • Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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
Other: Control	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality	6 and 12 months
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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): August 27, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: shock; Critical care; fluid resuscitation; Intensive Care; Microcirculation; risk stratification; SDF-measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: DAMIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No