Direct Assessment of Microcirculation In Shock (DAMIS)

NCT04173221 | Completed

• 1 other identifier: DAMIS
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 5

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.

Conditions

Microcirculation; Intensive Care; Shock

Keywords

Microcirculation; Intensive Care; Critical care; shock; risk stratification; SDF-measurement; fluid resuscitation

Outcome Measures

Primary Outcomes (1)

• mortality

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

  30 day

Secondary Outcomes (2)

• mortality

  6 and 12 months

• length of stay at ICU and hospital

  90 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

Other: Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician

Interventions

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

Intervention

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Younger than 18 years
• Anatomic reasons that inhibit sublingual measurement
• Lack of informed consent
• more than 4 hours after ICU admission

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (5)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine

Freiburg im Breisgau, Germany

Location

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Department of Cardiology, Heart Center Leipzig at University of Leipzig

Leipzig, Germany

Location

Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine

Stuttgart, Germany

Location

Related Publications (3)

• Bruno RR, Hernandez G, Thiele H, Kattan E, Jung C; DAMIS study group. A microcirculation-guided trial: never trying is worse than failing. Intensive Care Med. 2023 Dec;49(12):1555-1556. doi: 10.1007/s00134-023-07245-y. Epub 2023 Oct 9. No abstract available.

  PMID: 37812227 DERIVED

• Bruno RR, Hernandez G, Wollborn J, Saugel B, Jung C; of the DAMIS study group. Microcirculation information in clinical decision making: Rome wasn't built in a day. Intensive Care Med. 2023 Oct;49(10):1272-1273. doi: 10.1007/s00134-023-07216-3. Epub 2023 Sep 11. No abstract available.

  PMID: 37695331 DERIVED

• Bruno RR, Wollborn J, Fengler K, Flick M, Wunder C, Allgauer S, Thiele H, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Franz M, Saugel B, Kattan E, De Backer D, Bakker J, Hernandez G, Kelm M, Jung C. Direct assessment of microcirculation in shock: a randomized-controlled multicenter study. Intensive Care Med. 2023 Jun;49(6):645-655. doi: 10.1007/s00134-023-07098-5. Epub 2023 Jun 6.

  PMID: 37278760 DERIVED

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: February 1, 2020
• Primary Completion: August 27, 2022
• Study Completion: August 30, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

DE (5)