Septic ShockNCT05761522
Cardiovascular Effects of Norepinephrine
An observational study of Septic Shock, run by CHU de Reims at 1 site in France.
Trial summary
Previous studies of our team reported the improvement of myocardial contractility both on hemodynamic parameters (by transpulmonary thermodilution) and morphological (by transthoracic echocardiography: TTE), during the early phase of septic shock (during the first 4 hours management of septic shock). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- transthoracic echocardiography
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2023to 21 Dec 2025
- 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: Adult patients suffering from septic shock, after 24 hours of their diagnosis. Presenting with Mean arterial pressure (MAP)<65 mmHg or the target MAP For whom the physician in charge decided to increase the norepinephrine dose
Who may be able to join
- Adult patients >18 years old
- Septic shock after 24 hours from its diagnosis
- MAP<65 mmHg for which the physician in charge decided to increase NE
Who cannot join
- Patient under Dobutamine
- Pregnancy
- Do not resuscitation decision
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Cardiac Effects of Norepinephrine After the Initial Phase of Septic Shock
Previous studies of our team reported the improvement of myocardial contractility both on hemodynamic parameters (by transpulmonary thermodilution) and morphological (by transthoracic echocardiography: TTE), during the early phase of septic shock (during the first 4 hours management of septic shock).
However, one can wonder about the effect of NAD on myocardial cardiac ouput and contractility beyond the early phase of septic shock, more precisely beyond the first 24 hours. Indeed, while it continues to act on the "stressed" blood volume and the diastolic left ventricular perfusion by increasing the diastolic arterial pressure (DAP), it has been reported in old studies that beyond the early phase, the sensitivity of the β1-adrenergic receptors is altered due to the phenomenon of internalization of these receptors, leading to a reduction of the myocardial response to catecholamines.
Read more
The investigators can then wonder whether norepinephrine still exerts a positive effect on myocardial contractility via the increase in DAP, despite an alteration of the β1-adrenergic pathway.
To answer this question, the investigators proposed to evaluate the effects of norepinephrine by TTE on cardiac contractility after the initial phase.
Read the detailed description
Patients presenting with septic shock for 24 hours or more and meeting the inclusion criteria may be included.
The course of the study will be as follows:
T0: collection (as part of usual care) of clinical circulatory parameters (heart rate, systolic/diastolic/mean blood pressure) and biological parameters (arterial lactate and ScVo2) and performance of echocardiography.
Parameters collected during TTE:
- Concerning the main judgment criterion and the secondary judgment criteria:
- Left ventricular ejection fraction (LVEF) by the Simpson Biplane method,
- Cardiac output and cardiac index by continuity equation (measurement of left ventricular outflow chamber (mm) and sub-aortic time-velocity integral (cm/s)).
- Tricuspid Annular Systolic Excursion (TAPSE) (mm)
- S wave at the tricuspid ring (cm/s)
- Other parameters collected systematically:
- Surface of the left ventricle (end-systolic and end-diastolic),
- Global strain of the left ventricle
- Mitral Annular Plane Systolic Excursion (MAPSE) (mm)
- Left ventricular filling pressure (LVRP) (at the mitral annulus, E, A, e', S' waves, E/A ratio, E/e');
- Maximum tricuspid regurgitation velocity (m/s) to estimate systolic pulmonary arterial pressure (PAPs) (mmHg)
T1: After the clinician in charge introduces or increases norepinephrine to achieve MAP ≥ 65mmHg, T1 will be when the goal of MAP ≥ 65mmHg is reached. This will be the target MAP for the management of septic shock of the patient in question according to the recommendations of learned societies.
Collection of clinical and biological circulatory parameters and performance of the TTE. The parameters collected will be the same as at T0.
- Conditions
- Septic Shock
- Being tested
- transthoracic echocardiography
- Keywords
- ECHOCARDIOGRAPHY, CARDIAC FUNCTION, NOREPINEPHRINE, SEPTIC SHOCK
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographyOther
- Concerning the main judgment criterion and the secondary judgment criteria:
- Left ventricular ejection fraction (LVEF) by the Simpson Biplane method,
- Cardiac output and cardiac index by continuity equation (measurement of left ventricular outflow chamber (mm) and sub-aortic time-velocity integral (cm/s)).
- Tricuspid Annular Systolic Excursion (TAPSE) (mm)
- S wave at the tricuspid ring (cm/s)
- Other parameters collected systematically:
- Surface of the left ventricle (end-systolic and end-diastolic),
- Global strain of the left ventricle
- Mitral Annular Plane Systolic Excursion (MAPSE) (mm)
- Left ventricular filling pressure (LVRP) (at the mitral annulus, E, A, e', S' waves, E/A ratio, E/e');
- Maximum tricuspid regurgitation velocity (m/s) to estimate systolic pulmonary arterial pressure (PAPs) (mmHg)
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic shock for 24 hours or more | Adult patients suffering from septic shock, after 24 hours of their diagnosis. Presenting with Mean arterial pressure (MAP)<65 mmHg or the target MAP For whom the physician in charge decided to increase the norepinephrine dose Receives: Other: transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the increase of Norepinephrine dose after restoring MAP on cardiac contractility evaluated by TTE : the left ventricular ejection fraction
Measured: through study completion, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start21 Apr 2023
- Primary completion21 Mar 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761522
- Sponsor's protocol ID
- PZ23020*
- Status last verified
- Aug 2024
- First submitted
- 7 Feb 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Effects of Norepinephrine After the Initial Phase of Septic Shock
- ClinicalTrials.gov ID
- NCT05761522
- Acronym / sponsor ID
- PZ23020*
- Conditions
- Septic Shock
- Keywords
- ECHOCARDIOGRAPHY, CARDIAC FUNCTION, NOREPINEPHRINE, SEPTIC SHOCK
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Mar 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 9 Mar 2023 (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.
Previous studies of our team reported the improvement of myocardial contractility both on hemodynamic parameters (by transpulmonary thermodilution) and morphological (by transthoracic echocardiography: TTE), during the early phase of septic shock (during the first 4 hours management of septic shock).
However, one can wonder about the effect of NAD on myocardial cardiac ouput and contractility beyond the early phase of septic shock, more precisely beyond the first 24 hours. Indeed, while it continues to act on the "stressed" blood volume and the diastolic left ventricular perfusion by increasing the diastolic arterial pressure (DAP), it has been reported in old studies that beyond the early phase, the sensitivity of the β1-adrenergic receptors is altered due to the phenomenon of internalization of these receptors, leading to a reduction of the myocardial response to catecholamines.
The investigators can then wonder whether norepinephrine still exerts a positive effect on myocardial contractility via the increase in DAP, despite an alteration of the β1-adrenergic pathway.
To answer this question, the investigators proposed to evaluate the effects of norepinephrine by TTE on cardiac contractility after the initial phase.
Detailed description
Patients presenting with septic shock for 24 hours or more and meeting the inclusion criteria may be included.
The course of the study will be as follows:
T0: collection (as part of usual care) of clinical circulatory parameters (heart rate, systolic/diastolic/mean blood pressure) and biological parameters (arterial lactate and ScVo2) and performance of echocardiography.
Parameters collected during TTE:
- Concerning the main judgment criterion and the secondary judgment criteria:
- Left ventricular ejection fraction (LVEF) by the Simpson Biplane method,
- Cardiac output and cardiac index by continuity equation (measurement of left ventricular outflow chamber (mm) and sub-aortic time-velocity integral (cm/s)).
- Tricuspid Annular Systolic Excursion (TAPSE) (mm)
- S wave at the tricuspid ring (cm/s)
- Other parameters collected systematically:
- Surface of the left ventricle (end-systolic and end-diastolic),
- Global strain of the left ventricle
- Mitral Annular Plane Systolic Excursion (MAPSE) (mm)
- Left ventricular filling pressure (LVRP) (at the mitral annulus, E, A, e', S' waves, E/A ratio, E/e');
- Maximum tricuspid regurgitation velocity (m/s) to estimate systolic pulmonary arterial pressure (PAPs) (mmHg)
T1: After the clinician in charge introduces or increases norepinephrine to achieve MAP ≥ 65mmHg, T1 will be when the goal of MAP ≥ 65mmHg is reached. This will be the target MAP for the management of septic shock of the patient in question according to the recommendations of learned societies.
Collection of clinical and biological circulatory parameters and performance of the TTE. The parameters collected will be the same as at T0.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septic shock for 24 hours or more | – | Other: transthoracic echocardiographyAdult patients suffering from septic shock, after 24 hours of their diagnosis. Presenting with Mean arterial pressure (MAP)<65 mmHg or the target MAP For whom the physician in charge decided to increase the norepinephrine dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from septic shock, after 24 hours of their diagnosis. Presenting with Mean arterial pressure (MAP)<65 mmHg or the target MAP For whom the physician in charge decided to increase the norepinephrine dose
Key inclusion criteria (3 listed)
- Adult patients >18 years old
- Septic shock after 24 hours from its diagnosis
- MAP<65 mmHg for which the physician in charge decided to increase NE
Key exclusion criteria (3 listed)
- Patient under Dobutamine
- Pregnancy
- Do not resuscitation decision
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 |
|---|---|---|
| transthoracic echocardiography* Concerning the main judgment criterion and the secondary judgment criteria: * Left ventricular ejection fraction (LVEF) by the Simpson Biplane method, * Cardiac output and cardiac index by continuity equation (measurement of left ventricular outflow chamber (mm) and sub-aortic time-velocity integral (cm/s)). * Tricuspid Annular Systolic Excursion (TAPSE) (mm) * S wave at the tricuspid ring (cm/s) * Other parameters collected systematically: * Surface of the left ventricle (end-systolic and end-diastolic), * Global strain of the left ventricle * Mitral Annular Plane Systolic Excursion (MAPSE) (mm) * Left ventricular filling pressure (LVRP) (at the mitral annulus, E, A, e', S' waves, E/A ratio, E/e'); * Maximum tricuspid regurgitation velocity (m/s) to estimate systolic pulmonary arterial pressure (PAPs) (mmHg) | Other | Patients with septic shock for 24 hours or more |
Primary outcome
The effect of the increase of Norepinephrine dose after restoring MAP on cardiac contractility evaluated by TTE : the left ventricular ejection fraction
Time frame: through study completion, an average of 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
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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.
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 CHU de Reims at 1 site in France.
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 3 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 22 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 France. 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 Olfa Hamzaoui (3 10 73 69 73 ext. 0033, ohamzaoui@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the increase of Norepinephrine dose after restoring MAP on cardiac contractility evaluated by TTE : the left ventricular ejection fraction (time frame: through study completion, an average of 30 minutes). 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 22 Aug 2024.