Septic ShockNCT05355961
Effect of Norepinephrine Administration on Ventricular Systolic Function in Septic Shock
An observational study of Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This observational, pharmacological, prospective study aims to assess the improvement of ventricular systolic function mediated by norepinephrine (NE) administration in preload non-responders septic shock patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2022to 20 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Preload non-responder patients admitted to the ICU with a diagnosis of septic shock.
Who may be able to join
- less than 6 hours from the diagnosis of septic shock
- ongoing vasopressor therapy by continuous intravenous infusion of norepinephrine
- treating physician's decision to increase norepinephrine dose
Who cannot join
- preload responsiveness assessed through dynamic indices
- pregnancy
- myocardial disfunction due to active cardiac disease
- inadequate acoustic window for transthoracic echocardiography
- need for emergency treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
About this study
Official title: Effect of NorEpinephrine Administration on Ventricular Systolic Function in Septic Shock Patients: the ENESySS Study
This observational, pharmacological, prospective study aims to assess the improvement of ventricular systolic function mediated by norepinephrine (NE) administration in preload non-responders septic shock patients. Left ventricular outflow tract velocity time integral (LVOT-VTI) is an echocardiographic index of ventricular systolic function and it will be measured at different NE dosages.
Read the detailed description
Norepinephrine (NE) is recommended as first line vasopressor in septic shock. Besides increasing arterial tone and thus arterial pressure, NE improves cardiac output (CO) as a result of two main mechanisms: (i) the increase in venous return due to venoconstriction, in case of preload responsiveness, (ii) the improvement of coronary perfusion through augmentation of diastolic arterial pressure. Experimental data show that NE may incrase cardiac output by exerting also a direct β1-adrenergic stimulation on ventricular myocardial fibers. However, there are few clinical data dealing with the direct effect of NE administration on ventricular systolic function in human septic shock.
Our study aims to demonstrate that norepinephrine administration in early septic shock preload non-responder patients may improve left ventricular outflow tract velocity time integral (LVOT-VTI), measured by trans-thoracic echocardiography (TTE). We will include patients requiring an increase of NE dose for clinical need according to treating physician's decision. For each enrolled patient we will record standard hemodynamic data and perform TTE before NE dosage change (T0). After the increase of NE infusion rate targeting clinical need, a second set (T1) of hemodynamic and TTE data will be obtained.
All TTE examinations will be performed by two experienced and certified clinicians according to current guidelines. After being acquired, all TTE data will be independently analyzed by both clinicians and averaged. LVOT-VTI will be measured in the left ventricular outflow tract on the apical five-chamber (A5C) view. Referring to available literature data, we expect a mean LVOT-VTI of about 18 cm in our patients and we will consider clinically relevant an increase of 15% in LVOT-VTI from T 0 to T 1. We calculated that at least 30 patients need to be enrolled considering an alpha of 0.05 and a power of 80%. The benefits deriving from this study lay in the possibility of improving the clinical understanding of septic shock derived hemodynamic derangements and of widening therapeutic perspectives. Such an information meets the increasing topical need to customize medical interventions, especially in the context of critically ill patients.
- Conditions
- Septic Shock
- Keywords
- NorEpinephrine, Septic Shock, Beta-1adrenergic effect, Ventricular Systolic Function
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of LVOT-VTI
LVOT-VTI will be measured before and after increasing NE dose. An increase by 15% in LVOT-VTI will be considered clinically relevant.
Measured: 1 hour
Secondary outcomes (3)
Variation of left ventricle end-systolic elastance
Observe the effect of increasing NE infusion rate on left ventricle end-systolic elastance.
Measured: 1 hour
Variation of tricuspid annulus plane systolic excursion
Observe the effect of increasing NE infusion rate on tricuspid annulus plane systolic excursion.
Measured: 1 hour
Variation of LVOT-VTI, left ventricle end-systolic elastance and tricuspid annulus plane systolic excursion in patients with pre-existing depressed left ventricular systolic function.
Observe the effect of increasing NE infusion rate on ventricular systolic function in patients with preexisting depressed left ventricular systolic function defined by a LVEF ≤ 45%.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Mar 2022
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Carelli, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355961
- Sponsor's protocol ID
- 4774
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NorEpinephrine Administration on Ventricular Systolic Function in Septic Shock Patients: the ENESySS Study
- ClinicalTrials.gov ID
- NCT05355961
- Acronym / sponsor ID
- 4774
- Conditions
- Septic Shock
- Keywords
- NorEpinephrine, Septic Shock, Beta-1adrenergic effect, Ventricular Systolic Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 2 May 2022 (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 observational, pharmacological, prospective study aims to assess the improvement of ventricular systolic function mediated by norepinephrine (NE) administration in preload non-responders septic shock patients. Left ventricular outflow tract velocity time integral (LVOT-VTI) is an echocardiographic index of ventricular systolic function and it will be measured at different NE dosages.
Detailed description
Norepinephrine (NE) is recommended as first line vasopressor in septic shock. Besides increasing arterial tone and thus arterial pressure, NE improves cardiac output (CO) as a result of two main mechanisms: (i) the increase in venous return due to venoconstriction, in case of preload responsiveness, (ii) the improvement of coronary perfusion through augmentation of diastolic arterial pressure. Experimental data show that NE may incrase cardiac output by exerting also a direct β1-adrenergic stimulation on ventricular myocardial fibers. However, there are few clinical data dealing with the direct effect of NE administration on ventricular systolic function in human septic shock.
Our study aims to demonstrate that norepinephrine administration in early septic shock preload non-responder patients may improve left ventricular outflow tract velocity time integral (LVOT-VTI), measured by trans-thoracic echocardiography (TTE). We will include patients requiring an increase of NE dose for clinical need according to treating physician's decision. For each enrolled patient we will record standard hemodynamic data and perform TTE before NE dosage change (T0). After the increase of NE infusion rate targeting clinical need, a second set (T1) of hemodynamic and TTE data will be obtained.
All TTE examinations will be performed by two experienced and certified clinicians according to current guidelines. After being acquired, all TTE data will be independently analyzed by both clinicians and averaged. LVOT-VTI will be measured in the left ventricular outflow tract on the apical five-chamber (A5C) view. Referring to available literature data, we expect a mean LVOT-VTI of about 18 cm in our patients and we will consider clinically relevant an increase of 15% in LVOT-VTI from T 0 to T 1. We calculated that at least 30 patients need to be enrolled considering an alpha of 0.05 and a power of 80%. The benefits deriving from this study lay in the possibility of improving the clinical understanding of septic shock derived hemodynamic derangements and of widening therapeutic perspectives. Such an information meets the increasing topical need to customize medical interventions, especially in the context of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Preload non-responder patients admitted to the ICU with a diagnosis of septic shock.
Key inclusion criteria (3 listed)
- less than 6 hours from the diagnosis of septic shock
- ongoing vasopressor therapy by continuous intravenous infusion of norepinephrine
- treating physician's decision to increase norepinephrine dose
Key exclusion criteria (5 listed)
- preload responsiveness assessed through dynamic indices
- pregnancy
- myocardial disfunction due to active cardiac disease
- inadequate acoustic window for transthoracic echocardiography
- need for emergency treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of LVOT-VTI
Time frame: 1 hour
LVOT-VTI will be measured before and after increasing NE dose. An increase by 15% in LVOT-VTI will be considered clinically relevant.
3 secondary outcomes
Variation of left ventricle end-systolic elastance
Time frame: 1 hour
Variation of tricuspid annulus plane systolic excursion
Time frame: 1 hour
Variation of LVOT-VTI, left ventricle end-systolic elastance and tricuspid annulus plane systolic excursion in patients with pre-existing depressed left ventricular systolic function.
Time frame: 1 hour
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 21 May 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.
Simone Carelli, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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 21 May 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 Italy. 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?
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?
Variation of LVOT-VTI (time frame: 1 hour). 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 21 May 2024.