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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05355961
Other study ID # 4774
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date May 20, 2024

Study information

Verified date April 2022
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 20, 2024
Est. primary completion date May 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - preload responsiveness assessed through dynamic indices - pregnancy - myocardial disfunction due to active cardiac disease - inadequate acoustic window for transthoracic echocardiography - need for emergency treatment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma RM

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 hour
Secondary Variation of left ventricle end-systolic elastance Observe the effect of increasing NE infusion rate on left ventricle end-systolic elastance. 1 hour
Secondary Variation of tricuspid annulus plane systolic excursion Observe the effect of increasing NE infusion rate on tricuspid annulus plane systolic excursion. 1 hour
Secondary 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%. 1 hour
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