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Direct Assessment of Microcirculation In Shock (DAMIS)

Primary Purpose

Microcirculation, Intensive Care, Shock

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician
Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Microcirculation focused on measuring Microcirculation, Intensive Care, Critical care, shock, risk stratification, SDF-measurement, fluid resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mortality
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
length of stay at ICU and hospital
relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay

Full Information

First Posted
November 15, 2019
Last Updated
May 2, 2023
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT04173221
Brief Title
Direct Assessment of Microcirculation In Shock (DAMIS)
Official Title
Direct Assessment of Microcirculation In Shock (DAMIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 27, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microcirculation, Intensive Care, Shock
Keywords
Microcirculation, Intensive Care, Critical care, shock, risk stratification, SDF-measurement, fluid resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
Masking
Investigator
Masking Description
Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician
Intervention Description
Sublingual SDF-Measurement at admission and after 24h, with communication and interpreting checklist to the treating physician
Intervention Type
Other
Intervention Name(s)
Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician
Intervention Description
Sublingual SDF-Measurement at admission and after 24h, without communication and interpreting checklist to the treating physician
Primary Outcome Measure Information:
Title
mortality
Description
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
Time Frame
30 day
Secondary Outcome Measure Information:
Title
mortality
Description
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
Time Frame
6 and 12 months
Title
length of stay at ICU and hospital
Description
relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Cardiology, Pulmonary Disease and Vascular Medicine
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine
City
Freiburg im Breisgau
Country
Germany
Facility Name
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Department of Cardiology, Heart Center Leipzig at University of Leipzig
City
Leipzig
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine
City
Stuttgart
Country
Germany

12. IPD Sharing Statement

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Direct Assessment of Microcirculation In Shock (DAMIS)

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