orepinephrine alone vs Norepinephrine and Dobutamine in cardiogenic shock : a randomised, opened, cross-over study. Heart SHOCK-NORDOB Study

Phase 1

• Conditions: Cardiogenic Shock; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001270-41-FR
• Lead Sponsor: CHRU NANCY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 42

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
Pregnancy
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified