Critical IllnessHERICANCT06536231
Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
A study testing Remote ischemic conditioning in people with Critical Illness, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2024to 31 Mar 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18 years,
- admitted to the intensive care unit,
- monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
- decision by the physician in charge to perform passive leg raising.
Who cannot join
- pregnancy,
- advanced malignancy,
- peripheral artery disease affecting both arms,
- head trauma,
- deep vein thrombosis in the lower limbs,
- intra-abdominal hypertension, defined as an intra-abdominal pressure greater than 12 mmHg.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Intensive care
Kaunas, 50161
Andrius Pranskunas, PhD, prof.
Andrius Pranskunas, PhD, prof.
About this study
The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.
Read the detailed description
The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR).
Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.
- Conditions
- Critical Illness
- Being tested
- Remote ischemic conditioning
- Keywords
- Remote ischemic conditioning, Passive leg raising, Hemodynamic, Perfusion index, Fluid responsiveness
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| Passive leg raising and Remote ischemic conditioning | Experimental | Supine position was followed by the passive leg raising (PLR) maneuver. After completing the PLR test, participants were placed in the supine position for 5 min. Thereafter, remote ischemic conditioning (RIC) was performed. After the RIC procedure, the patient is left in supine position for 5 minutes. Then the PLR test was repeated, after which the participants were placed in a supine position for another 5 min at rest. When the patient fluid responder, physician in charge may decide to perform a fluid infusion (500 mL of crystaloids). The PLR test can also be performed to make decision for fluid removal. This decision is triggered by a negative PLR test in the later phase of ICU treatment. If the physician has decided to administer a fluids, systemic hemodynamics and peripheral perfusion index are measured immediately after completion of the fluid infusion. Receives: Procedure: Remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff.
Measured: During RIC procedure
Maximal change in cardiac index during RIC procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff.
Measured: During RIC procedure
Maximal change in peripheral perfusion index during RIC procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
Measured: During RIC procedure
The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR).
The maximum changes in these parameters, as determined by the RIC procedure and PLR, were identified, and their correlation was subsequently calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
Measured: During RIC procedure, as well as during passive leg raising.
The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure.
The maximum changes in these parameters, as measured during PLR before and after the RIC procedure, were identified. Subsequently, the correlation between these changes was calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
Measured: During PLR both before and after the RIC procedure.
Secondary outcomes (1)
The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR.
In this context, PI is measured on the arm where the blood pressure cuff is placed. Upon cuff release, both the maximum PI and the time to reach this maximum are recorded.
Measured: During RIC procedure, as well as during PLR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- Investigators
- Andrius Pranskunas, PhD, prof., Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536231
- Sponsor's protocol ID
- 1.2
- Acronym
- HERICA
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT06536231
- Acronym / sponsor ID
- HERICA / 1.2
- Conditions
- Critical Illness
- Keywords
- Remote ischemic conditioning, Passive leg raising, Hemodynamic, Perfusion index, Fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Aug 2024 (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.
The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.
Detailed description
The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR).
Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive leg raising and Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningSupine position was followed by the passive leg raising (PLR) maneuver. After completing the PLR test, participants were placed in the supine position for 5 min. Thereafter, remote ischemic conditioning (RIC) was performed. After the RIC procedure, the patient is left in supine position for 5 minutes. Then the PLR test was repeated, after which the participants were placed in a supine position for another 5 min at rest. When the patient fluid responder, physician in charge may decide to perform a fluid infusion (500 mL of crystaloids). The PLR test can also be performed to make decision for fluid removal. This decision is triggered by a negative PLR test in the later phase of ICU treatment. If the physician has decided to administer a fluids, systemic hemodynamics and peripheral perfusion index are measured immediately after completion of the fluid infusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged over 18 years,
- admitted to the intensive care unit,
- monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
- decision by the physician in charge to perform passive leg raising.
Key exclusion criteria (6 listed)
- pregnancy,
- advanced malignancy,
- peripheral artery disease affecting both arms,
- head trauma,
- deep vein thrombosis in the lower limbs,
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 | Passive leg raising and Remote ischemic conditioning |
Primary outcome
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure
Time frame: During RIC procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff.
Maximal change in cardiac index during RIC procedure
Time frame: During RIC procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff.
Maximal change in peripheral perfusion index during RIC procedure
Time frame: During RIC procedure
Change in this parameter is determined during each inflation and release of the blood pressure cuff. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR).
Time frame: During RIC procedure, as well as during passive leg raising.
The maximum changes in these parameters, as determined by the RIC procedure and PLR, were identified, and their correlation was subsequently calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure.
Time frame: During PLR both before and after the RIC procedure.
The maximum changes in these parameters, as measured during PLR before and after the RIC procedure, were identified. Subsequently, the correlation between these changes was calculated. The perfusion index is measured on a hand that is not equipped with a blood pressure cuff.
1 secondary outcome
The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR.
Time frame: During RIC procedure, as well as during PLR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
Andrius Pranskunas, PhD, prof. principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Critical Illness, 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 4 inclusion and 6 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 13 Aug 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 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.
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?
Contact Andrius Pranskunas, PhD, prof. (+37037326425, andrius.pranskunas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure (time frame: During RIC procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.