NCT05355961

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

May 21, 2024

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

March 23, 2022

Last Update Submit

May 20, 2024

Conditions

Septic Shock

Keywords

NorEpinephrineSeptic ShockBeta-1adrenergic effectVentricular Systolic Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Variation of left ventricle end-systolic elastance

    1 hour

  • Variation of tricuspid annulus plane systolic excursion

    1 hour

  • 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.

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Preload non-responder patients admitted to the ICU with a diagnosis of septic shock.

You may qualify if:

  • 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

You may not qualify if:

  • preload responsiveness assessed through dynamic indices
  • pregnancy
  • myocardial disfunction due to active cardiac disease
  • inadequate acoustic window for transthoracic echocardiography
  • need for emergency treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Biospecimen

Retention: NONE RETAINED

Blood samples for blood gas analysis

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Simone Carelli, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

May 2, 2022

Study Start

March 10, 2022

Primary Completion

May 20, 2024

Study Completion

May 20, 2024

Last Updated

May 21, 2024

Record last verified: 2022-04

Locations

IT(1)