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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002707-22 | EudraCT Number |
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After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| administration of norepinephrine by dynamic elastance | Experimental | The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance |
|
| control administration of norepinephrine | Other | The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Administration and weaning of norepinephrine is based on dynamic arterial elastance |
|
| Measure | Description | Time Frame |
|---|---|---|
| The duration of treatment with norepinephrine. | Mean duration time of norepinephrine administration calculated in hours | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The total dose of norepinephrine infused during the study period | Day 28 | |
| ICU duration of stay in day | Day 28 | |
| Total urine output in ml during the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Grégoire Guinot, Doctor | CHU Amiens-Picardie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | Picardie | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25598221 | Background | Guinot PG, Bernard E, Levrard M, Dupont H, Lorne E. Dynamic arterial elastance predicts mean arterial pressure decrease associated with decreasing norepinephrine dosage in septic shock. Crit Care. 2015 Jan 19;19(1):14. doi: 10.1186/s13054-014-0732-5. | |
| 28120005 | Result | Guinot PG, Abou-Arab O, Guilbart M, Bar S, Zogheib E, Daher M, Besserve P, Nader J, Caus T, Kamel S, Dupont H, Lorne E. Monitoring dynamic arterial elastance as a means of decreasing the duration of norepinephrine treatment in vasoplegic syndrome following cardiac surgery: a prospective, randomized trial. Intensive Care Med. 2017 May;43(5):643-651. doi: 10.1007/s00134-016-4666-z. Epub 2017 Jan 24. |
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine | Drug | The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate). |
|
|
| Day 28 |
| Total of crystalloid an colloid infused during the study period (ml) | Day 28 |
| the rate of arterial lactate at the end of norepinephrine administration | Day 28 |
| Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period | Day 28 |
| SOFA score | SOFA score measured at the end of norepinephrine administration | Day 28 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |