MedDataX Logo

Direct Assessment of Microcirculation In Shock (DAMIS)

NCT ID: NCT04173221

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic Investigation and Prediction of Shock

NCT03043170

Shock
COMPLETED

Microcirculation in Prehospital Medicine

NCT04265066

Emergencies
COMPLETED

Detection of Exhaled Methane Levels in Hemorrhagic Shock

NCT04987411

Hemorrhagic Shock Trauma
UNKNOWN

Use of Ultrasound in the Initial Management of Patients in Shock in the Nancy Emergency Department

NCT06573541

Shock
ACTIVE_NOT_RECRUITING

The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care

NCT04478045

Shock Ultrasonography Differential Diagnosis +2 more
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microcirculation Intensive Care Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

DIAGNOSTIC

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Control

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Older than 18 years
2. 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

1. Younger than 18 years
2. Anatomic reasons that inhibit sublingual measurement
3. Lack of informed consent
4. more than 4 hours after ICU admission
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status

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

Freiburg im Breisgau, , Germany

Site Status

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

Hamburg, , Germany

Site Status

Department of Cardiology, Heart Center Leipzig at University of Leipzig

Leipzig, , Germany

Site Status

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

Stuttgart, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37812227 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37695331 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37278760 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DAMIS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pathway and Urgent caRe of Dyspneic Patient at the Emergency Department in LorrainE District (PURPLE)
NCT03194243 UNKNOWN
Mobile Stroke Unit for Pre-hospital Emergency Care
NCT05330715 UNKNOWN NA
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
NCT07085221 RECRUITING NA
Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
NCT03270319 TERMINATED
Effectiveness of the MINUTES Bundle for Initial 30-Minute Management of Undifferentiated Circulatory Shock in the Emergency Department
NCT07209735 NOT_YET_RECRUITING NA
Correlation of Clinical and Laboratory Findings and Diuretic Efficacy in Patients With Edematous States in the Emergency Department
NCT03967717 COMPLETED
Evaluation of Pupillary Distension Reflexes, as a Tool for the Monitoring of Analgesia for Patients in Intensive Care.
NCT02843893 COMPLETED NA
Volume Responsiveness By Ultrasound Of Carotid Blood Flow In Patients With Cardiogenic Shock
NCT05271227 COMPLETED
Diagnostic Performance of the Mitral Annulus Velocity Variation Measured by Tissue Doppler to Evaluate the Fluid Responsiveness During the Initial Management of Shock in Patients Admitted to the Emergency Department
NCT05888974 RECRUITING
Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output
NCT04202432 COMPLETED
Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient
NCT02638350 COMPLETED NA
Non-Invasive Shock: Differentiating Shock in the Emergency Department
NCT02164851 COMPLETED
Functional Hemodynamic Assessment in Shocked Patients in the Pediatric Intensive Care Unit
NCT06720493 NOT_YET_RECRUITING
The Epidemiology and Approach to Differentiating Etiologies of Shock in the Emergency Department
NCT02164799 COMPLETED
Cerebrovascular Hemodynamics in Patients With ARDS.
NCT03949738 COMPLETED
Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER
NCT01743105 COMPLETED NA
Low Dose of Norepinephrine Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock
NCT07053163 COMPLETED NA
Sonography in Hypotension and Cardiac Arrest in the Emergency Department.
NCT01419106 COMPLETED NA
B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
NCT03136198 COMPLETED PHASE2
Systolic Time Intervals in the Diagnosis of Heart Failure in Emergency Departement
NCT02161445 COMPLETED
Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)
NCT01763853 UNKNOWN PHASE4
Point-of-care Ultrasound Teledidactic Teaching for Prehospital Emergency Personnel
NCT06824675 COMPLETED NA
The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
NCT05752383 RECRUITING
Norepinephrine in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock
NCT06311903 RECRUITING NA
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)
NCT06345352 ACTIVE_NOT_RECRUITING