Direct Assessment of Microcirculation In Shock (DAMIS)

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT04173221

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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 more than 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.

Condition or Disease	Intervention/Treatment	Phase
Microcirculation Intensive Care Shock	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Investigator)

Masking Description:

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

Primary Purpose:

Diagnostic

Official Title:

Direct Assessment of Microcirculation In Shock (DAMIS)

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

measurement of microcirculation [at admission and after 24 hours]
measurement of sublingual microcirculation by using MicroScan® microscope

Secondary Outcome Measures

mortality [Discharge, after 6 and 12 months]
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
lenght of stay at ICU and hospital [Discharge]
relationship of bedside measurement of microcirculation with the clinical outcome in terms of lenght of stay
macrocirculation [at admission and after 24 hours]
measurement of microcirculation leads to different macro-circulatory parameters