Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Dobutamine; Norepinephrine

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