MicrocirculationVIPPERNCT04169204
Very Old Intensive Care Patients - Perfusion
An observational study of Microcirculation and Intensive Care, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Microcirculation, Intensive Care, Very Old Intensive Care Patients
- What is being tested?
- Measurement of microcirculation
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- 19 May 2020to 30 May 2024
- Phase
- Observational
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Very Old Intensive Care Patients with shock
Who may be able to join
- ≥ 80 years
- Acute ICU admission
- Shock at the time point of admission to the ICU or in the first 3 hours defined as Lactate ≥ 2 mmol/l AND need for vasoactive substances to maintain a MAP ≥ 65 mmHg in the presence of adequate volume status
Who cannot join
- < 80 years
- Inaccessibility for sublingual measurement
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: Very Old Intensive Care Patients - Perfusion (VIPPER)
Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels <100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.
- Being tested
- Measurement of microcirculation
- Keywords
- Microcirculation, Intensive Care, Critical care, shock, Very Old Intensive Care Patients, risk stratification, SDF-measurement
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of microcirculationDiagnostic test
As a simple clinical test, every patient will receive the assessment capillary refill time and mottling-score. Additionally, repetitive measurements of lactate will be done. The SDF-camera (MicroVision Medical®, Amsterdam, Netherlands) will measure sublingual microcirculation at different time points (Admission and 24h).
What is being measured
The primary outcome is the main question the study is designed to answer.
bedside measurement of sublingual microcirculation
measurement of sublingual microcirculation by using MicroScan® microscope
Measured: admission of the intensive care unit
bedside measurement of sublingual microcirculation
measurement of sublingual microcirculation by using MicroScan® microscope
Measured: after 24 hours
Secondary outcomes (3)
Mortality
Measured: after 30 days, 6 months and 12 months
Length of stay at ICU
Measured: tdays from admission of the intensive care unit until discharge
Use of Vasopressors and fluids
Measured: days from admission of the intensive care unit until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start19 May 2020
- Primary completion31 May 2023
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 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
- NCT04169204
- Sponsor's protocol ID
- 19-021
- Acronym
- VIPPER
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bruno RR, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Marinova R, Kanschik D, Binnebossel S, Spomer A, Guidet B, Leaver S, Flaatten H, Szczeklik W, Mikiewicz M, De Lange DW, Quenard S, Beil M, Kelm M, Jung C. Sublingual microcirculatory assessment on admission independently predicts the outcome of old intensive care patients suffering from shock. Sci Rep. 2024 Oct 27;14(1):25668. doi: 10.1038/s41598-024-77357-y.
PubMed 39463395
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Old Intensive Care Patients - Perfusion (VIPPER)
- ClinicalTrials.gov ID
- NCT04169204
- Acronym / sponsor ID
- VIPPER / 19-021
- Keywords
- Microcirculation, Intensive Care, Critical care, shock, Very Old Intensive Care Patients, risk stratification, SDF-measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 19 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.
Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels <100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Very Old Intensive Care Patients with shock
Key inclusion criteria (3 listed)
- ≥ 80 years
- Acute ICU admission
- Shock at the time point of admission to the ICU or in the first 3 hours defined as Lactate ≥ 2 mmol/l AND need for vasoactive substances to maintain a MAP ≥ 65 mmHg in the presence of adequate volume status
Key exclusion criteria (3 listed)
- < 80 years
- Inaccessibility for sublingual measurement
- no informed consent
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 |
|---|---|---|
| Measurement of microcirculationAs a simple clinical test, every patient will receive the assessment capillary refill time and mottling-score. Additionally, repetitive measurements of lactate will be done. The SDF-camera (MicroVision Medical®, Amsterdam, Netherlands) will measure sublingual microcirculation at different time points (Admission and 24h). | Diagnostic test | – |
Primary outcome
bedside measurement of sublingual microcirculation
Time frame: admission of the intensive care unit
measurement of sublingual microcirculation by using MicroScan® microscope
bedside measurement of sublingual microcirculation
Time frame: after 24 hours
measurement of sublingual microcirculation by using MicroScan® microscope
3 secondary outcomes
Mortality
Time frame: after 30 days, 6 months and 12 months
Length of stay at ICU
Time frame: tdays from admission of the intensive care unit until discharge
Use of Vasopressors and fluids
Time frame: days from admission of the intensive care unit until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 39463395Bruno RR, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Marinova R, Kanschik D, Binnebossel S, Spomer A, Guidet B, Leaver S, Flaatten H, Szczeklik W, Mikiewicz M, De Lange DW, Quenard S, Beil M, Kelm M, Jung C. Sublingual microcirculatory assessment on admission independently predicts the outcome of old intensive care patients suffering from shock. Sci Rep. 2024 Oct 27;14(1):25668. doi: 10.1038/s41598-024-77357-y.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculation and Intensive Care, run by Heinrich-Heine University, Duesseldorf at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
bedside measurement of sublingual microcirculation (time frame: admission of the intensive care unit). The study lists 2 primary outcomes in all. 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 NCT04169204, which also lists 1 linked publication.
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 9 Jan 2024; AzTrials last refreshed its copy on 2 Nov 2026.