Cardiovascular Effects of Norepinephrine

NCT05761522 | Recruiting

• 1 other identifier: PZ23020*
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Septic Shock

Keywords

ECHOCARDIOGRAPHY; CARDIAC FUNCTION; NOREPINEPHRINE; SEPTIC SHOCK

Outcome Measures

Primary Outcomes (1)

• The effect of the increase of Norepinephrine dose after restoring MAP on cardiac contractility evaluated by TTE : the left ventricular ejection fraction

  through study completion, an average of 30 minutes

Study Arms (1)

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

Other: transthoracic echocardiography

Interventions

transthoracic echocardiography OTHER

* 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)

Patients with septic shock for 24 hours or more

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patient under Dobutamine
• Pregnancy
• Do not resuscitation decision

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Olfa Hamzaoui

CONTACT

3 10 73 69 73; ohamzaoui@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 9, 2023
• Study Start: April 21, 2023
• Primary Completion: March 21, 2025
• Study Completion: December 21, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

FR (1)