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Routine use of corticoids became standard therapy
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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
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Brain death patients who are selected for organ donation very often suffer from haemodynamic instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. However,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.
When patients are treated in the ICU only as possible organ donators they will be assessed for eligibility for the study. Iv hydrocortisone or placebo will be administered every 6 hours. Several hormonal samples will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | hydrocortisone treatment 50mg iv x4 |
|
| 2 | Placebo Comparator | Placebo iv every 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone | Drug | hydrocortisone 50mg iv. every 6 hours |
| |
| sodium chloride |
| Measure | Description | Time Frame |
|---|---|---|
| dosage and time on norepinephrine treatment | in ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Hormone levels and number of organs donated | Hospital treatment |
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Inclusion Criteria: all have to be fulfilled
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stepani Bendel, MD | Kuopio University Hospital | Study Director |
| Esko Ruokonen, MD, PhD | Kuopio University Hospital | Study Director |
| Jyrki Tenhunen, MD, PhD | Tampere UH | Study Chair |
| Anna-Maija Antman, MD | Tampere UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | 70211 | Finland | |||
| Tampere University Hospital |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| D013345 | Subarachnoid Hemorrhage |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
sodium chloride every 6 hours iv |
|
| Tampere |
| Finland |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |