ICU Norepinephrine Load

NCT ID: NCT05032261

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-12-31

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.

Conditions

Circulatory Collapse and Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group 1: surviving Patients

Patients surviving within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine

Circulatory shock with norepinephrine in ICU

Intervention Type: DRUG

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

Circulatory shock with norepinephrine in ICU

Intervention Type: DRUG

Circulatory shock with norepinephrine in ICU

Interventions

Circulatory shock with norepinephrine in ICU

Circulatory shock with norepinephrine in ICU

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Muller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

Ceausu D, Boulet N, Roger C, Alonso S, Lefrant JY, Boisson C, Mura T, Muller L. CRITICAL NOREPINEPHRINE DOSE TO PREDICT EARLY MORTALITY DURING CIRCULATORY SHOCK IN INTENSIVE CARE: A RETROSPECTIVE STUDY IN 3423 ICU PATIENTS OVER 4-YEAR PERIOD. Shock. 2024 Nov 1;62(5):682-687. doi: 10.1097/SHK.0000000000002454. Epub 2024 Aug 28.

Reference Type: RESULT

PMID: 39193888 (View on PubMed)

Other Identifiers

LOCAL/2021/DC-01

Identifier Type: -

Identifier Source: org_study_id