Circulatory Collapse and ShockICU_NE_LOADNCT05032261
ICU Norepinephrine Load
An observational study of Circulatory Collapse and Shock, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulatory Collapse and Shock
- What is being tested?
- Circulatory shock with norepinephrine in ICU
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with circulatory shock admitted in intensive care unit (ICU) and receiving norepinephrine. All patients older than 18 years recorded between January 1, 2015 and December 31, 2019 were included. Patients with circulatory shock without norepinephrine were excluded.
Who may be able to join
- Age > 18 years
- circulatory shock and admitted in ICU
- with norepinephrine
- Exclusion Criteria : Patient without norepinephrine or missing data.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Circulatory Collapse and Shock
- Being tested
- Circulatory shock with norepinephrine in ICU
- Keywords
- Norepinephrine load dose, vasopressor dose intensity, vasopressor exposure
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulatory shock with norepinephrine in ICUDrug
Circulatory shock with norepinephrine in ICU
| Study group | Role | What they receive |
|---|---|---|
| Group 1: surviving Patients | Patients surviving within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine Receives: 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 Receives: Drug: Circulatory shock with norepinephrine in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity
Measured: Day 5
Secondary outcomes (3)
Intensity
Intensity mortality relationship according to norepinephrine duration
Measured: Day 5
Time/Dose Ratio
ratio between time of use and cumulative dose
Measured: Day 5
Norepinephrine dose
score of increasing norepinephrine dose
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circulatory Collapse and ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Muller, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032261
- Sponsor's protocol ID
- LOCAL/2021/DC-01
- Acronym
- ICU_NE_LOAD
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2021
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39193888
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Load and Relationship With Prognosis in Critically Patients With Circulatory Shock
- ClinicalTrials.gov ID
- NCT05032261
- Acronym / sponsor ID
- ICU_NE_LOAD / LOCAL/2021/DC-01
- Conditions
- Circulatory Collapse and Shock
- Keywords
- Norepinephrine load dose, vasopressor dose intensity, vasopressor exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: surviving Patients | – | Drug: Circulatory shock with norepinephrine in ICUPatients surviving within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine |
| Group 2: Deceased patients | – | Drug: Circulatory shock with norepinephrine in ICUPatients deceased within 5 days of the date of ICU admission for circulatory shock and receiving norepinephrine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with circulatory shock admitted in intensive care unit (ICU) and receiving norepinephrine. All patients older than 18 years recorded between January 1, 2015 and December 31, 2019 were included. Patients with circulatory shock without norepinephrine were excluded.
Key inclusion criteria (4 listed)
- Age > 18 years
- circulatory shock and admitted in ICU
- with norepinephrine
- Exclusion Criteria : Patient without norepinephrine or missing data.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulatory shock with norepinephrine in ICUCirculatory shock with norepinephrine in ICU | Drug | Group 1: surviving Patients, Group 2: Deceased patients |
Primary outcome
Mortality
Time frame: Day 5
Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity
3 secondary outcomes
Intensity
Time frame: Day 5
Time/Dose Ratio
Time frame: Day 5
Norepinephrine dose
Time frame: Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 39193888Ceausu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Muller, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Collapse and Shock, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05032261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.