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| Name | Class |
|---|---|
| Ospedale San Raffaele | OTHER |
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The purpose of this study is to evaluate efficacy and safety of i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support.
Cardiogenic shock is characterized by a decrease in cardiac output and increased ventricular pressures, with subsequent symptoms and signs of systemic hypoperfusion. In spite of the multiple pharmacological chances the in-hospital mortality rate is still very high (around 60% of patients) and nowadays there is not a therapeutic "reference standard" associated with an improved survival at short and midterm. Adrenaline is a mainstay of resuscitation therapy during cardiopulmonary arrest, however, it is not clear whether this inotrope actually facilitates an improvement in patients affected by cardiogenic shock. In a small local evidence-based experience, contrary to current opinion, it has been shown that adrenaline may still have a role in the treatment of patients with low output state. This phase II study tests the hypothesis that adrenaline infusion, integrated in a multistep approach at increasing intensity, can be a valid support with limited side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adrenaline | Experimental | i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adrenaline | Drug | i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 60 days | number of successes | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of i.v. infusion with adrenaline | 30 days | |
| Adrenaline maximum dose | 30 days | |
| Time to weaning from beginning with pharmacological therapy and mechanical ventricular support |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niguarda Hospital | Milan | MI | 20162 | Italy | ||
| Ospedale San Raffaele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30100052 | Result | Morici N, Oliva F, Ajello S, Stucchi M, Sacco A, Cipriani MG, De Bonis M, Garascia A, Gagliardone MP, Melisurgo G, Russo CF, La Vecchia C, Frigerio M, Pappalardo F. Management of cardiogenic shock in acute decompensated chronic heart failure: The ALTSHOCK phase II clinical trial. Am Heart J. 2018 Oct;204:196-201. doi: 10.1016/j.ahj.2018.07.009. Epub 2018 Jul 20. |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 30 days |
| Length of stay | 30 days |
| Sum of medical staff support and nursing-care hours dedicated to each patient | Within patient hospitalization, each day from day 1 to day 30 |
| Membrane oxygenation | Escalation to venoarterial extracorporeal membrane oxygenation (VA-ECMO) | 60 days |
| Milan |
| 20132 |
| Italy |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |