Clinical trial NCT03340779: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock
Official title: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiogenic Shock
Keywords: Norepinephrine
Dobutamine
Shock
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 first hours : strategy 1, norepinephrine alone with increased dose or norepinephrine + dobutamine 0.5 hour : wash-out (decrease of norepinephrine dose or weaning of dobutamine) 3 last hours : strategy 2, crossover, norepinephrine alone with increased dose or norepinephrine + dobutamine
Primary purpose: TREATMENT

Brief summary: Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.

Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.

The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.

The secondary objectives were :

* To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
* To evaluate the tolerance of the treatments
* To evaluate the dose and the admistration's kinetics of the treatments


Eligibility criteria: Inclusion Criteria:

* Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac index (CI) \< 2,2 L/min/m² or CI \< 2,5 L/min/m² under vasopressor/inotropic treatment and organ hypoperfusion signs : mottles, capillary refill time , urine output \< 0,5 mL/kg/hour during at least one hour ou renal replacement therapy, consciouness impairment, pulmonary oedema, hyperlactatemia (\> 2 mmoL/L)
* Mean arterial pressure \> 65 mmHg under norepinephrine treatment
* Patients with social coverage

Exclusion Criteria:

* \< 18 years old
* Pregnancy
* Inclusion in other drug study
* Poisonings with cardiotoxicants
* Patient with intra-aortic ballon pump, extracorporeal life support
* Patient under guardianship

Primary outcomes:
measure: Obtention of a optimal cardiac output
timeFrame: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary outcomes:
measure: Change in hemodynamic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Occurence of arrythmia
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in hemodynamic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: All-cause mortality
timeFrame: Day 28
measure: Change in hemodynamic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in metabolic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in metabolic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in metabolic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in metabolic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Change in metabolic parameters
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
measure: Occurence of arrythmia
timeFrame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: CHU Nancy-Brabois
Study officials:
References: