ICU Norepinephrine Load (ICU_NE_LOAD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Circulatory Collapse and Shock
• Intervention / Treatment: Drug: Circulatory shock with norepinephrine in ICU

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Laurent Muller, MD, PhD; Phone Number: +33.(0)4.66.68.33.31; Email: laurent.muller@chu-nimes.fr

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
    • Contact: Laurent MULLER, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with circulatory shock admitted in intensive care unit (ICU) and receiving norepinephrine. We included all patients older than 18 years recorded between January 1, 2015 and December 31 to December, 31, 2019. Patients with circulatory shock without norepinephrine were excluded.

Description

Inclusion Criteria:

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

Exclusion Criteria : Patient without norepinephrine or missing data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity	Day 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Laurent Muller, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Norepinephrine load dose; vasopressor dose intensity; vasopressor exposure
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: LOCAL/2021/DC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No