EUCTR2017-001270-41-FRActive, not recruitingPhase 1
orepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study - HEARTSCHOCK-NORDOB
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CHRU NANCY
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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
- •- 0rgan hypoperfusion signs :
- •a) mottles,
- •b) capillary refill time greater or equal to 3 seconds ,
- •c) urine output < 0,5 mL/kg/hour during at least one hour or renal replacement therapy,
- •d) consciouness impairment,
- •e) pulmonary oedema,
- •f) hyperlactatemia (> 2 mmoL/L)
- •- Mean arterial pressure > 65 mmHg under norepinephrine treatement
- •- Patients with social coverage
- •- Patient having given his / her consent, free, informed and in writing. If not, consent will be obtained from a family member / support person, if present. As soon as possible, the patient will be informed and his / her consent will be requested for the possible continuation of the research
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •< 18 years old
- •Inclusion in other drug study in cardiogenic shock , inclusion in study with medical device (for instance valve replacement)
- •Poisonings with cardiotoxicants
- •Patient with intra-aortic ballon pump, extracorporeal life support, ventricular support device
- •Patient under guardianship
Investigators
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