Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

Last updated: November 8, 2017
Sponsor: Central Hospital, Nancy, France
Overall Status: Active - Not Recruiting

Phase

3

Condition

Low Blood Pressure (Hypotension)

Heart Failure

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT03340779
2017-001270-41
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiacindex (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatmentand organ hypoperfusion signs : mottles, capillary refill time , urine output < 0,5mL/kg/hour during at least one hour ou renal replacement therapy, consciounessimpairment, pulmonary oedema, hyperlactatemia (> 2 mmoL/L)

  • Mean arterial pressure > 65 mmHg under norepinephrine treatment

  • Patients with social coverage

Exclusion

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

Study Design

Total Participants: 40
Study Start date:
January 15, 2018
Estimated Completion Date:
May 01, 2020

Connect with a study center

  • CHU Nancy-Brabois

    Vandoeuvre les nancy, 54500
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.