NCT04173221

Direct Assessment of Microcirculation In Shock (DAMIS)

Completed NA Last updated 6 May 2023

What this trial tests

NA trial testing Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician in Microcirculation in 141 participants. Completed in 30 August 2022.

Timeline

1 February 2020

Primary endpoint
27 August 2022

30 August 2022

Quick facts

Lead sponsor	Heinrich-Heine University, Duesseldorf
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	141
Start date	1 February 2020
Primary completion	27 August 2022
Estimated completion	30 August 2022
Sites	5 locations across Germany

Drugs / interventions tested

• Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician
• Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician

Conditions studied

• Microcirculation — all drugs for Microcirculation →
• Intensive Care — all drugs for Intensive Care →
• Shock — all drugs for Shock →

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, any sex, with Microcirculation or Intensive Care. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Direct assessment of microcirculation in shock: a randomized-controlled multicenter study.
   Bruno RR, Wollborn J, Fengler K, Flick M, et al · · 2023 · cited 55× · PMID 37278760 · DOI 10.1007/s00134-023-07098-5
2. [Evaluation of the microcirculation in critically ill patients : Relevance, practical possibilities and scientific evidence].
   Wollborn J, Jung C, Göbel U, Bruno RR. · · 2020 · cited 1× · PMID 32803320 · DOI 10.1007/s00101-020-00832-4