ICU Norepinephrine Load

• Conditions: Circulatory Collapse and Shock
• Interventions: Drug: Circulatory shock with norepinephrine in ICU

• Registration Number: NCT05032261
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Norepinephrine is recommended as first-line vasopressor in critically ill patients, regardless of shock etiology. Its advantages over dopamine and/or epinephrine have been demonstrated, especially by reducing tachycardia events. The current guidelines recommend a mean arterial pressure of at least 65 mmHg that in the resuscitation from sepsis-induced hypoperfusion. Some study reported that delay in initiation of vasopressor therapy was associated with an increase mortality risk in patient with septic shock .The recent experts' opinion suggest that " vasopressors should be started early, before (complete) completion of fluid ressuscitation ".

In the event of refractory septic shock, high-dose vasopressors may be used. The precise maximal dose of norepinephrine associated with mortality excess has been poorly studied. High doses have been defined by a cutoff value ranging from 0.5 μg/kg/min to 2 μg/kg/min and recently by 1 μg/kg/min for mortality at 90% and by 0,75 μg/kg/min for mortality at 60%. Furthermore, an increasing vasopressor dosing intensity during the first 24 hours after shock septic was associated with increased mortality depending of fluid administration. If a threshold value of norepinephrine score can be obtained, it could indicate the association with another vasopressor such as vasopressin or surrogates.

The primary aim of the present study aimed to confirm if a given norepinephrine dose is associated with mortality. The secondary aims were the link between mortality and norepinephrine duration, cumulative dose in order to build a score that predicts a futility of increasing norepinephrine dose.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study Start: 2021-09
• Study First Posted: 2021-09-02
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 18 years
• circulatory shock and admitted in ICU
• with norepinephrine

Exclusion Criteria : Patient without norepinephrine or missing data.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: surviving Patients	Circulatory shock with norepinephrine in ICU	Patients surviving within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine
Group 2: Deceased patients	Circulatory shock with norepinephrine in ICU	Patients deceased within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine

Primary Outcome Measures

Name	Time	Method
Mortality	Day 5	Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity

Secondary Outcome Measures

Name	Time	Method
Intensity	Day 5	Intensity mortality relationship according to norepinephrine duration
Time/Dose Ratio	Day 5	ratio between time of use and cumulative dose
Norepinephrine dose	Day 5	score of increasing norepinephrine dose

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France