Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock

February 26, 2025 updated by: Matej Podbregar, General and Teaching Hospital Celje

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 or more years old
  • sepsis
  • septic shock

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluids

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.
Drug: Fluid therapy
Infusion of 8 ml/Kg/30' or 16 ml/kg/60' of fluids.
Drug: Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
Other Names:
  • Vasopressin infusion
Active Comparator: No fluids

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.
Drug: Noradrenaline infusion
dosage will be titrated in order to obtain mean arterial pressure target
Other Names:
  • Vasopressin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 24 hours after treatment start
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.
From enrollment to 24 hours after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure optimal target
Time Frame: From enrollment to 24 hours after treatment start
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.
From enrollment to 24 hours after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General and Teaching Hospital Celje

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70/2025/6-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only the investigators involved in the study at General Hospital in Celje - Internal Intensive Care Unit (SBC - OIIM) will manage participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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