Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock (SHOCK-NORDOB)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 3

Conditions: Cardiogenic Shock

Treatments: Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03340779

2017-001270-41

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Norepinephrine alone

Experimental group

Description:

Administration of norepinephrine with increasing dose

Treatment:

Drug: Norepinephrine

Norepinephrine plus Dobutamine

Active Comparator group

Description:

Administration of norepinephrine and dobutamine

Treatment:

Drug: Norepinephrine