Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

NCT ID: NCT03340779

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2020-05-01

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

Conditions

Cardiogenic Shock

Keywords

Norepinephrine; Dobutamine; Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Norepinephrine alone

Administration of norepinephrine with increasing dose

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

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.

Norepinephrine plus Dobutamine

Administration of norepinephrine and dobutamine

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Dobutamine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Nancy-Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

Facility Contacts

Thomas Auchet, MD

Role: primary

Other Identifiers

2017-001270-41

Identifier Type: -

Identifier Source: org_study_id