Septic ShockPhase 1/2NCT04644926
The Effect of Remote Ischemic Conditioning on the Microcirculation in Sepsis
A Phase 1/2 study testing Remote ischemic conditioning in people with Septic Shock and Sepsis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Feb 2018to 1 Sep 2020
- Phase
- Phase 1/2
- 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
- Patients with sepsis or septic shock within the first 24 h after ICU admission.
Who cannot join
- age < 18 years,
- pregnancy,
- advanced malignancy,
- peripheral artery disease affecting both arms,
- oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Hospital of Lithuanian university of health sciences
Kaunas, LT-50161
About this study
Official title: Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.
Read the detailed description
This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.
- Conditions
- Septic Shock, Sepsis
- Being tested
- Remote ischemic conditioning
- Keywords
- Microcirculation, Remote ischemic conditioning, Sepsis
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Remote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later. Receives: Procedure: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
The differences in MFI and PPV between pre- and post-RIC performance.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Feb 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
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 Septic ShockStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrius Pranskunas, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644926
- Sponsor's protocol ID
- BE-2-78
- Status last verified
- Feb 2021
- First submitted
- 19 Nov 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiudulaite I, Belousoviene E, Vitkauskiene A, Pranskunas A. Effects of remote ischemic conditioning on microcirculatory alterations in patients with sepsis: a single-arm clinical trial. Ann Intensive Care. 2021 Apr 7;11(1):55. doi: 10.1186/s13613-021-00848-y.
PubMed 33829305
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Ischemic Conditioning on Microcirculatory Alterations in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04644926
- Acronym / sponsor ID
- BE-2-78
- Conditions
- Septic Shock, Sepsis
- Keywords
- Microcirculation, Remote ischemic conditioning, Sepsis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 25 Nov 2020 (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.
This study is an evaluation of the effect of Remote ischemic conditioning on sublingual microcirculation in patients with sepsis.
Detailed description
This prospective open-label trial is performed in mixed ICU in a tertiary teaching hospital. Investigators include patients with sepsis or septic shock within the first 24 h after ICU admission. Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. RIC is performed at inclusion and repeated 12 h and 24 h later. Sublingual microcirculatory measurements are obtained before and after each RIC procedure, using incidence dark field (IDF) device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningRemote ischemic conditioning (RIC) is performed at inclusion and repeated 12 h and 24 h later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with sepsis or septic shock within the first 24 h after ICU admission.
Key exclusion criteria (5 listed)
- age < 18 years,
- pregnancy,
- advanced malignancy,
- peripheral artery disease affecting both arms,
- oral mucosal inflammation or injury or technical difficulties in obtaining sublingual images.
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 |
|---|---|---|
| Remote ischemic conditioningRemote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes. | Procedure or surgery | Remote ischemic conditioning |
Primary outcome
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV)
Time frame: 30 minutes
The differences in MFI and PPV between pre- and post-RIC performance.
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 3 Mar 2021.
- Derived from this study: PubMed 33829305Kiudulaite I, Belousoviene E, Vitkauskiene A, Pranskunas A. Effects of remote ischemic conditioning on microcirculatory alterations in patients with sepsis: a single-arm clinical trial. Ann Intensive Care. 2021 Apr 7;11(1):55. doi: 10.1186/s13613-021-00848-y.
- Individual participant dataSharing planned: No
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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?
A Phase 1/2 study testing Remote ischemic conditioning in people with Septic Shock and Sepsis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 1 inclusion and 5 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 3 Mar 2021. 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 Lithuania. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Microvascular flow index (MFI) and Proportion of perfused small vessels (PPV) (time frame: 30 minutes). 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 NCT04644926, 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 3 Mar 2021.