Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01367743
• Date of registration: 10/05/2011
• Prospective Registration: Yes
• Primary sponsor: Central Hospital, Nancy, France
• Public title: Study Comparing the Efficacy and Tolerability of Epinephrine and Norepinephrine in Cardiogenic Shock OptimaCC
• Scientific title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine
• Date of first enrolment: September 2011
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01367743
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Philippe VIGNON, Dr
• Affiliation: CHU Limoges

Key inclusion & exclusion criteria

Inclusion Criteria:

- man or woman older than 18 years

- cardiogenic shock due to myocardial infarction treated by angioplasty

- SAP < 90 MM Hg or MAP < 65 mm Hg without vasopressor or vasopressor necessity

- sign of tissue hypoperfusion

- cardiac index < 2.2 l/mn/m2 in the absence of vasopressive or inotropic therapy

- pulmonary artery occlusion pressure > 15 mmHg or echocardiographic evidence of high
pressure (mitral profile)

- exclusion of covert hypovolemia : Delta PP if feasible should be > 13% (patient
adapted to the ventilator and sinus rhythm) and /or no response to passive leg raising

- ejection fraction < 40% in ultrasound without inotrope support. This criteria will not
be taken into account in instances of treatment with dopamine, norepinephrine,
epinephrine, dobutamine or milrinone.

Exclusion Criteria:

- shock of other origin

- immediate indications for mechanical assistance device

- minor aged patients

- patients for whom written consent - by patient or family - has not been obtained.
Given the seriousness of the medical situation at the time of inclusion, patient
consent will be difficult if not impossible to obtain. The inclusion will only be
possible after information is provided and consent is obtained from a family member.
As soon as possible, protocol information will be issued to the patient in order to
obtain consent for continuance.

- cardiac arrest with early signs of cerebral anoxia.

- septic, toxic and obstructive cardiomyopathy

- arrhythmogenic cardiomyopathy

- patient with coronary insufficiency

- patient with ventricular rhythm disorders

- patient treated with a medicine listed in contre indication

- patient without social assurance

- patient major under legal protection or safeguard justice



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cardiogenic Shock

Intervention(s)

Drug: epinephrine perfusion

Drug: norepinephrine perfusion

Primary Outcome(s)

Compared effects of investigated drugs on cardiac index [Time Frame: H0; H2, H4, H6, H12, H24, H48 and H72]

Secondary Outcome(s)

SVO2 [Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72.]

Lactate clearance [Time Frame: H0, H2, H6, H12, H24 and H48]

refractory cardiogenic shock [Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72.]

cardiac double product [Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72.]

catecholamine doses [Time Frame: H0, H24, H48 and H72]

BNP [Time Frame: H0, H24, H48 and H72]

cardiac power index [Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72.]

organ failure (SOFA Score) [Time Frame: H0, H24, H48 and H72]

Troponin [Time Frame: H0, H24, H48 and H72]

pro/anti-inflammatory cytokines [Time Frame: H0, H24, H48 and H72]

heart rate [Time Frame: H0, H2, H4, H6, H12, H24, H48 and H72]

Secondary ID(s)

2009-017081-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors