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The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output.
The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dobutamine | Active Comparator | Start Dobutamine. If no success switch to Dopamine. |
|
| Dopamine | Active Comparator | Start Dopamine. If no success switch to Dobutamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine | Drug | Start Dobutamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dopamine. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral tissue oxygen saturation | Cerebral tissue oxygen saturation (and derived parameters FTOE, HbD and Total Hb as secondary outcomes) measured by near-infrared spectroscopy after achieving normal blood pressure | during study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output | Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry | during treatment |
| Cardiac output | Cardiac output and derived parameters (Cardiac index, stroke volumen, stroke index) as measured by electrical cardiovelocimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel B Schmid, Dr. med. | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center, Ulm University | Ulm | Baden-Wurttemberg | 89075 | Germany |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004280 | Dobutamine |
| D004298 | Dopamine |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
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|
| Dopamine | Drug | Start Dopamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dobutamine. |
|
| during study medication |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |