MicrocirculationNCT04173221
Direct Assessment of Microcirculation In Shock (DAMIS)
A study testing 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 in people with Microcirculation and Intensive Care, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation, Intensive Care, Shock
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Feb 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Younger than 18 years
- Anatomic reasons that inhibit sublingual measurement
- Lack of informed consent
- more than 4 hours after ICU admission
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Department of Anaesthesiology and Critical Care, Medical Centre - University of Freiburg, Faculty of Medicine
Freiburg im Breisgau
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg
Department of Cardiology, Heart Center Leipzig at University of Leipzig
Leipzig
Robert-Bosch-Krankenhaus, Department of Anesthesiology and Intensive Care Medicine
Stuttgart
About this study
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
- Being 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
- Keywords
- Microcirculation, Intensive Care, Critical care, shock, risk stratification, SDF-measurement, fluid resuscitation
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician |
| Control | Other | Not described Receives: Other: Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
Measured: 30 day
Secondary outcomes (2)
mortality
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
Measured: 6 and 12 months
length of stay at ICU and hospital
relationship of bedside measurement of microcirculation with the clinical outcome in terms of length of stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Feb 2020
- Primary completion27 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173221
- Sponsor's protocol ID
- DAMIS
- Status last verified
- May 2023
- First submitted
- 15 Nov 2019
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37812227Bruno 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.
PubMed 37695331Bruno 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.
PubMed 37278760
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Assessment of Microcirculation In Shock (DAMIS)
- ClinicalTrials.gov ID
- NCT04173221
- Acronym / sponsor ID
- DAMIS
- Conditions
- Microcirculation, Intensive Care, Shock
- Keywords
- Microcirculation, Intensive Care, Critical care, shock, risk stratification, SDF-measurement, fluid resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 27 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Sublingual SDF-Measurement at admission and after 24h, with or without communication and interpreting checklist to the treating physician
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Younger than 18 years
- Anatomic reasons that inhibit sublingual measurement
- Lack of informed consent
- more than 4 hours after ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual SDF-Measurement with communication and interpreting checklist to the treating physicianSublingual SDF-Measurement at admission and after 24h, with communication and interpreting checklist to the treating physician | Other | Intervention |
| Sublingual SDF-Measurement without communication and interpreting checklist to the treating physicianSublingual SDF-Measurement at admission and after 24h, without communication and interpreting checklist to the treating physician | Other | Control |
Primary outcome
mortality
Time frame: 30 day
relationship of bedside measurement of microcirculation with the clinical outcome in terms of mortality
2 secondary outcomes
mortality
Time frame: 6 and 12 months
length of stay at ICU and hospital
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 37812227Bruno 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.
- Derived from this study: PubMed 37695331Bruno 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.
- Derived from this study: PubMed 37278760Bruno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Microcirculation and Intensive Care, run by Heinrich-Heine University, Duesseldorf at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173221, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.