NCT03340779

Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DRUG	Norepinephrine	After obtention of a mean arterial pressure (MAP) of 65 mmHg with infusion of norepinephrine, patients with cardiogenic shock receive for 3 hours either increasing doses of norepinephrine (with a maximal MAP of 85 mmHg) or dobutamine. There is a wash-out phase of 30 minutes (decrease of norepinephrine dose or weaning of dobutamine). The third phase of the study is the administration of the comparator treatment during 3 hours. After the 6.5 hours of the study, the hemodynamic management is up to the physician.

Timeline

• Start date: 2018-01-15
• Primary completion: 2019-11-01
• Completion: 2020-05-01
• First posted: 2017-11-14
• Last updated: 2017-11-14

Locations

1 site across 1 country: France