Septic Shock Clinical Trial
Official title:
Effect of NorEpinephrine Administration on Ventricular Systolic Function in Septic Shock Patients: the ENESySS Study
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 |
Verified date | April 2022 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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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