- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05032261
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Laurent Muller, MD, PhD
- Telefonnummer: +33.(0)4.66.68.33.31
- E-mail: laurent.muller@chu-nimes.fr
Studiesteder
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-
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Nîmes Cedex 09, Frankrig, 30029
- CHU de Nimes - Hopital Universitaire Caremeau
-
Kontakt:
- Laurent MULLER, MD, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age > 18 years
- circulatory shock and admitted in ICU
- with norepinephrine
Exclusion Criteria : Patient without norepinephrine or missing data.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mortality
Tidsramme: Day 5
|
Mortality within 5 days of the date of ICU admission for circulatory shock according to norepinephrine intensity
|
Day 5
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Intensity
Tidsramme: Day 5
|
Intensity mortality relationship according to norepinephrine duration
|
Day 5
|
Time/Dose Ratio
Tidsramme: Day 5
|
ratio between time of use and cumulative dose
|
Day 5
|
Norepinephrine dose
Tidsramme: Day 5
|
score of increasing norepinephrine dose
|
Day 5
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Laurent Muller, MD, PhD, Centre Hospitalier Universitaire de Nîmes
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Stød
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Adrenerge alfa-agonister
- Adrenerge agonister
- Sympatomimetika
- Vasokonstriktormidler
- Noradrenalin
Andre undersøgelses-id-numre
- LOCAL/2021/DC-01
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