SepsisNCT06853574
Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock
A study testing Fluid therapy and Noradrenaline infusion in people with Sepsis and Septic Shock, run by General and Teaching Hospital Celje at 1 site in Slovenia.
Trial summary
Sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Fluid therapy and Noradrenaline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Feb 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 or more years old
- sepsis
- septic shock
Who cannot join
- lack of consent
- less than 18 years old
- pregnancy
- more than moderate aortic stenosis ( aortic valve area (AVA) < 1.4 cm2, aortic valve area indexed (AVAi) < 0.85, doppler velocity index (DVI) < 0.5)
- more than mild mitral regurgitation (vena contracta (VC) width <= 3 mm, mitral regurgitation (MR) effective regurgitant orifice area (EROA) < 20, MR regurgitant volume (RegV) < 30 ml)
- cardiac arrythmias (e.g. atrial fibrillation/flutter, frequent ventricular and supraventricular or nodal activity)
- renal replacement therapy
- other than continous modes of mechanical ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
General Hospital Celje
Celje, 3000
Matej Podbregar, 0038640215960, podbregar.matej@gmail.com
About this study
Official title: Changes in Ventriculo-arterial Coupling and Myocardial Work During Treatment of Sepsis and Septic Shock: a Prospective Interventional Study
Sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. The aim of the study is to assess how the treatment of sepsis and septic shock will modify myocardial work and ventriculo-arterial coupling, that can be considered as indicators of ventricular and arterial performance efficacy respectively. Each patient will be treated according to updated guidelines for sepsis and septic shock management, they will voluntarily be enrolled and they can decide to withdraw in each moment without any consequence on their treatment. The investigators, after receiving the consent, will collect patients' data, take blood samples and perform ultrasound measurements and then will start the treatment which can be based on fluids infusion, vasopressors or both. The investigators think that a modern cardiovascular assessment approach can be used to individually set the optimal blood pressure target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Fluid therapy, Noradrenaline infusion
- Keywords
- sepsis, septic shock, myocardial work, ventriculo-arterial coupling, ICU, intensive care
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapyDrug
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.
Noradrenaline infusionDrug
Also called Vasopressin infusion
dosage will be titrated in order to obtain mean arterial pressure target
| Study group | Role | What they receive |
|---|---|---|
| Fluids | Active comparator | The patients will be included in this arm on admission basing on the absence of peripheral edema, presence of apical A lines at lung ultrasound, inferior vena cava width < 2 cm and velocity-time integral (VTI) variation > 10%.
If the fluid therapy will not be effective, patients will also receive vasopressors. Receives: Drug: Fluid therapy; Drug: Noradrenaline infusion |
| No fluids | Active comparator | The patients will be included in this arm on admission basing on the presence of peripheral edema, presence of apical B lines at lung ultrasound, inferior vena cava width > 2 cm and velocity-time integral (VTI) variation < 10%.
In this arm the patients will receive vasopressors with an initial mean arterial pressure target of 65 mmHg; then the investigators will target to 80-85 mmHg to observe tha changes in ventriculo-arterial coupling. Receives: Drug: Noradrenaline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ventriculo-arterial coupling
ventricular coupling will be analyzed on admission and its changes after treatment will be observed. To analyze ventriculo-arterial coupling, invasive blood pressure through either a radial or femoral arterial line will be collected and then data will be plotted into iElastance app available on smartphones to get the also knows as single beat determination ventriculo-arterial coupling.
Measured: From enrollment to 24 hours after treatment start
Changes in myocardial work
Myocardial work will be analyzed on admission and its changes after treatment will be observed. To realize this, a transthoracic cardiac ultrasound will be performed and the images will be transferred to EchoPAC from General Electrics (GE) to get the pressure-volume strain analysis also known as myocardial work.
Measured: From enrollment to 24 hours after treatment start
Secondary outcomes (1)
Mean arterial pressure optimal target
The study aims to identify the optimal mean arterial pressure (MAP) target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling. To realize this, invasive blood pressure through either a radial or femoral arterial line will be collected and then data will be plotted into iElastance app available on smartphones to get the also knows as single beat determination ventriculo-arterial coupling.
Measured: From enrollment to 24 hours after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General and Teaching Hospital Celje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Podbregar, General and Teaching Hospital Celje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853574
- Sponsor's protocol ID
- 70/2025/6-1
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the investigators involved in the study at General Hospital in Celje - Internal Intensive Care Unit (SBC - OIIM) will manage participant data.
Publications
Sunagawa K, Sagawa K, Maughan WL. Ventricular interaction with the loading system. Ann Biomed Eng. 1984;12(2):163-89. doi: 10.1007/BF02584229.
PubMed 6507965Kakihana Y, Nishida O, Taniguchi T, Okajima M, Morimatsu H, Ogura H, Yamada Y, Nagano T, Morishima E, Matsuda N; J-Land 3S Study Group. Efficacy and safety of landiolol, an ultra-short-acting beta1-selective antagonist, for treatment of sepsis-related tachyarrhythmia (J-Land 3S): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2020 Sep;8(9):863-872. doi: 10.1016/S2213-2600(20)30037-0. Epub 2020 Mar 31.
PubMed 32243865Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.
PubMed 24108526Nasrollahi-Shirazi S, Sucic S, Yang Q, Freissmuth M, Nanoff C. Comparison of the beta-Adrenergic Receptor Antagonists Landiolol and Esmolol: Receptor Selectivity, Partial Agonism, and Pharmacochaperoning Actions. J Pharmacol Exp Ther. 2016 Oct;359(1):73-81. doi: 10.1124/jpet.116.232884. Epub 2016 Jul 22.
PubMed 27451411Zhou X, Pan J, Wang Y, Wang H, Xu Z, Zhuo W. Left ventricular-arterial coupling as a predictor of stroke volume response to norepinephrine in septic shock - a prospective cohort study. BMC Anesthesiol. 2021 Feb 17;21(1):56. doi: 10.1186/s12871-021-01276-y.
PubMed 33596822Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
PubMed 11738311Zhou X, Zhang Y, Pan J, Wang Y, Wang H, Xu Z, Chen B, Hu C. Optimizing left ventricular-arterial coupling during the initial resuscitation in septic shock - a pilot prospective randomized study. BMC Anesthesiol. 2022 Jan 21;22(1):31. doi: 10.1186/s12871-021-01553-w.
PubMed 35062874Antonini-Canterin F, Poli S, Vriz O, Pavan D, Bello VD, Nicolosi GL. The Ventricular-Arterial Coupling: From Basic Pathophysiology to Clinical Application in the Echocardiography Laboratory. J Cardiovasc Echogr. 2013 Oct-Dec;23(4):91-95. doi: 10.4103/2211-4122.127408.
PubMed 28465893Andrei S, Bahr PA, Berthoud V, Popescu BA, Nguyen M, Bouhemad B, Guinot PG. Diuretics depletion improves cardiac output and ventriculo-arterial coupling in congestive ICU patients during hemodynamic de-escalation. J Clin Monit Comput. 2023 Aug;37(4):1035-1043. doi: 10.1007/s10877-023-01011-7. Epub 2023 Apr 25.
PubMed 37097337Bischoff AR, Stanford AH, McNamara PJ. Short-term ventriculo-arterial coupling and myocardial work efficiency in preterm infants undergoing percutaneous patent ductus arteriosus closure. Physiol Rep. 2021 Nov;9(22):e15108. doi: 10.14814/phy2.15108.
PubMed 34806325Demailly Z, Besnier E, Tamion F, Lesur O. Ventriculo-arterial (un)coupling in septic shock: Impact of current and upcoming hemodynamic drugs. Front Cardiovasc Med. 2023 May 30;10:1172703. doi: 10.3389/fcvm.2023.1172703. eCollection 2023.
PubMed 37324631Rehn M, Chew MS, Olkkola KT, Ingi Sigurethsson M, Yli-Hankala A, Hylander Moller M. Surviving sepsis campaign: International guidelines for management of sepsis and septic shock in adults 2021 - endorsement by the Scandinavian society of anaesthesiology and intensive care medicine. Acta Anaesthesiol Scand. 2022 May;66(5):634-635. doi: 10.1111/aas.14045. Epub 2022 Mar 6.
PubMed 35170043
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ventriculo-arterial Coupling and Myocardial Work During Treatment of Sepsis and Septic Shock: a Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06853574
- Acronym / sponsor ID
- 70/2025/6-1
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, myocardial work, ventriculo-arterial coupling, ICU, intensive care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- General and Teaching Hospital CeljeUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 3 Mar 2025 (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.
Sepsis is a term which describes an excessive response of the body to an infection and, if not promptly treated, can turn into septic shock a condition in which the organs don't receive enough oxygen to satisfy their needs. The aim of the study is to assess how the treatment of sepsis and septic shock will modify myocardial work and ventriculo-arterial coupling, that can be considered as indicators of ventricular and arterial performance efficacy respectively. Each patient will be treated according to updated guidelines for sepsis and septic shock management, they will voluntarily be enrolled and they can decide to withdraw in each moment without any consequence on their treatment. The investigators, after receiving the consent, will collect patients' data, take blood samples and perform ultrasound measurements and then will start the treatment which can be based on fluids infusion, vasopressors or both. The investigators think that a modern cardiovascular assessment approach can be used to individually set the optimal blood pressure target in sepsis and septic shock with the combined evaluation of myocardial work and ventriculo-arterial coupling.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluids | Active comparator | Drug: Fluid therapy, Drug: Noradrenaline infusionThe patients will be included in this arm on admission basing on the absence of peripheral edema, presence of apical A lines at lung ultrasound, inferior vena cava width < 2 cm and velocity-time integral (VTI) variation > 10%. If the fluid therapy will not be effective, patients will also receive vasopressors. |
| No fluids | Active comparator | Drug: Noradrenaline infusionThe patients will be included in this arm on admission basing on the presence of peripheral edema, presence of apical B lines at lung ultrasound, inferior vena cava width > 2 cm and velocity-time integral (VTI) variation < 10%. In this arm the patients will receive vasopressors with an initial mean arterial pressure target of 65 mmHg; then the investigators will target to 80-85 mmHg to observe tha changes in ventriculo-arterial coupling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or more years old
- sepsis
- septic shock
Key exclusion criteria (8 listed)
- lack of consent
- less than 18 years old
- pregnancy
- more than moderate aortic stenosis ( aortic valve area (AVA) < 1.4 cm2, aortic valve area indexed (AVAi) < 0.85, doppler velocity index (DVI) < 0.5)
- more than mild mitral regurgitation (vena contracta (VC) width <= 3 mm, mitral regurgitation (MR) effective regurgitant orifice area (EROA) < 20, MR regurgitant volume (RegV) < 30 ml)
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 |
|---|---|---|
| Fluid therapyInfusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids. | Drug | Fluids |
| Noradrenaline infusionAlso: Vasopressin infusiondosage will be titrated in order to obtain mean arterial pressure target | Drug | Fluids, No fluids |
Primary outcome
Changes in ventriculo-arterial coupling
Time frame: From enrollment to 24 hours after treatment start
ventricular coupling will be analyzed on admission and its changes after treatment will be observed. To analyze ventriculo-arterial coupling, invasive blood pressure through either a radial or femoral arterial line will be collected and then data will be plotted into iElastance app available on smartphones to get the also knows as single beat determination ventriculo-arterial coupling.
Changes in myocardial work
Time frame: From enrollment to 24 hours after treatment start
Myocardial work will be analyzed on admission and its changes after treatment will be observed. To realize this, a transthoracic cardiac ultrasound will be performed and the images will be transferred to EchoPAC from General Electrics (GE) to get the pressure-volume strain analysis also known as myocardial work.
1 secondary outcome
Mean arterial pressure optimal target
Time frame: From enrollment to 24 hours after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 6507965Sunagawa K, Sagawa K, Maughan WL. Ventricular interaction with the loading system. Ann Biomed Eng. 1984;12(2):163-89. doi: 10.1007/BF02584229.
- Background: PubMed 32243865Kakihana Y, Nishida O, Taniguchi T, Okajima M, Morimatsu H, Ogura H, Yamada Y, Nagano T, Morishima E, Matsuda N; J-Land 3S Study Group. Efficacy and safety of landiolol, an ultra-short-acting beta1-selective antagonist, for treatment of sepsis-related tachyarrhythmia (J-Land 3S): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2020 Sep;8(9):863-872. doi: 10.1016/S2213-2600(20)30037-0. Epub 2020 Mar 31.
- Background: PubMed 24108526Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.
- Background: PubMed 27451411Nasrollahi-Shirazi S, Sucic S, Yang Q, Freissmuth M, Nanoff C. Comparison of the beta-Adrenergic Receptor Antagonists Landiolol and Esmolol: Receptor Selectivity, Partial Agonism, and Pharmacochaperoning Actions. J Pharmacol Exp Ther. 2016 Oct;359(1):73-81. doi: 10.1124/jpet.116.232884. Epub 2016 Jul 22.
- Background: PubMed 33596822Zhou X, Pan J, Wang Y, Wang H, Xu Z, Zhuo W. Left ventricular-arterial coupling as a predictor of stroke volume response to norepinephrine in septic shock - a prospective cohort study. BMC Anesthesiol. 2021 Feb 17;21(1):56. doi: 10.1186/s12871-021-01276-y.
- Background: PubMed 11738311Chen CH, Fetics B, Nevo E, Rochitte CE, Chiou KR, Ding PA, Kawaguchi M, Kass DA. Noninvasive single-beat determination of left ventricular end-systolic elastance in humans. J Am Coll Cardiol. 2001 Dec;38(7):2028-34. doi: 10.1016/s0735-1097(01)01651-5.
- Background: PubMed 35062874Zhou X, Zhang Y, Pan J, Wang Y, Wang H, Xu Z, Chen B, Hu C. Optimizing left ventricular-arterial coupling during the initial resuscitation in septic shock - a pilot prospective randomized study. BMC Anesthesiol. 2022 Jan 21;22(1):31. doi: 10.1186/s12871-021-01553-w.
- Background: PubMed 28465893Antonini-Canterin F, Poli S, Vriz O, Pavan D, Bello VD, Nicolosi GL. The Ventricular-Arterial Coupling: From Basic Pathophysiology to Clinical Application in the Echocardiography Laboratory. J Cardiovasc Echogr. 2013 Oct-Dec;23(4):91-95. doi: 10.4103/2211-4122.127408.
- Background: PubMed 37097337Andrei S, Bahr PA, Berthoud V, Popescu BA, Nguyen M, Bouhemad B, Guinot PG. Diuretics depletion improves cardiac output and ventriculo-arterial coupling in congestive ICU patients during hemodynamic de-escalation. J Clin Monit Comput. 2023 Aug;37(4):1035-1043. doi: 10.1007/s10877-023-01011-7. Epub 2023 Apr 25.
- Background: PubMed 34806325Bischoff AR, Stanford AH, McNamara PJ. Short-term ventriculo-arterial coupling and myocardial work efficiency in preterm infants undergoing percutaneous patent ductus arteriosus closure. Physiol Rep. 2021 Nov;9(22):e15108. doi: 10.14814/phy2.15108.
- Background: PubMed 37324631Demailly Z, Besnier E, Tamion F, Lesur O. Ventriculo-arterial (un)coupling in septic shock: Impact of current and upcoming hemodynamic drugs. Front Cardiovasc Med. 2023 May 30;10:1172703. doi: 10.3389/fcvm.2023.1172703. eCollection 2023.
- Background: PubMed 35170043Rehn M, Chew MS, Olkkola KT, Ingi Sigurethsson M, Yli-Hankala A, Hylander Moller M. Surviving sepsis campaign: International guidelines for management of sepsis and septic shock in adults 2021 - endorsement by the Scandinavian society of anaesthesiology and intensive care medicine. Acta Anaesthesiol Scand. 2022 May;66(5):634-635. doi: 10.1111/aas.14045. Epub 2022 Mar 6.
- Individual participant dataSharing planned: No. Only the investigators involved in the study at General Hospital in Celje - Internal Intensive Care Unit (SBC - OIIM) will manage participant data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid therapy and Noradrenaline infusion in people with Sepsis and Septic Shock, run by General and Teaching Hospital Celje at 1 site in Slovenia.
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 8 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: opening soon, as of the sponsor's last update on 3 Mar 2025. 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 Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matej Prof. Dr. Podbregar, Intensive care medicine (+38640215960, podbregar.matej@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ventriculo-arterial coupling (time frame: From enrollment to 24 hours after treatment start). 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 NCT06853574, which also lists 12 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 3 Mar 2025.