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Completed

NCT Number: NCT05032261

ICU Norepinephrine Load

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Patient without norepinephrine or missing data.

Treatment and study plan

Circulatory shock with norepinephrine in ICU

Drug

Circulatory shock with norepinephrine in ICU

Primary outcomes

  1. Mortality

    Time frame: Day 5

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

Secondary outcomes

  1. Intensity

    Time frame: Day 5

    Intensity mortality relationship according to norepinephrine duration

  2. Time/Dose Ratio

    Time frame: Day 5

    ratio between time of use and cumulative dose

  3. Norepinephrine dose

    Time frame: Day 5

    score of increasing norepinephrine dose

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Norepinephrine Load and Relationship With Prognosis in Critically Patients With Circulatory Shock

Acronym: ICU_NE_LOAD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2021
Registry last updated
Dec 16, 2025

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.

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