Skip to main content
OpenTrials
Completed

NCT Number: NCT04173221

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine, Düsseldorf, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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 physician

Other

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

Primary outcomes

  1. mortality

    Time frame: 30 day

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

Secondary outcomes

  1. mortality

    Time frame: 6 and 12 months

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

  2. length of stay at ICU and hospital

    Time frame: 90 days

    relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.