CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 141 enrolled
Drug / intervention
Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04173221
NCT04173221N/ACompleted

Direct Assessment of Microcirculation In Shock (DAMIS)

Heinrich-Heine University, Duesseldorf·interventional·Posted Nov 21, 2019·Updated May 6, 2023

In Brief

A clinical study evaluating Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician and Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician for Microcirculation and 2 related conditions. Completed, enrolled 141 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartFeb 1, 2020
Primary CompletionAug 27, 2022
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.6 years ago

Interventions

Sublingual SDF-Measurement with communication and interpreting checklist to the treating physicianother

Sublingual SDF-Measurement at admission and after 24h, with communication and interpreting checklist to the treating physician

Sublingual SDF-Measurement without communication and interpreting checklist to the treating physicianother

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