Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05761522

Cardiovascular Effects of Norepinephrine

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

Location status: Recruiting

Location contact

Damien JOLLY

CONTACT

[email protected]

326788472 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patient under Dobutamine
  • Pregnancy
  • Do not resuscitation decision

Treatment and study plan

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)

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

    Time frame: through study completion, an average of 30 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Olfa Hamzaoui

CONTACT

[email protected]

3 10 73 69 73 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Cardiac Effects of Norepinephrine After the Initial Phase of Septic Shock

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.