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By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid restriction | Active Comparator | Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min |
|
| Catecholamine restriction | Active Comparator | Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalloid Solutions | Drug | crystalloid restrictive anesthesia protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Free flap survival rate | Rates of (partial) flap loss in each study arm | 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Period of hospitalization | Length of postoperative hospitalization in each study arm | up to 14 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Anker, MD | Contact | 0049 941 782 3110 | aanker@caritasstjosef.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Regensburg | Recruiting | Regensburg | 93053 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22929242 | Background | Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73. | |
| 25539313 | Background | Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-299. doi: 10.1097/PRS.0000000000000839. |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D002395 | Catecholamines |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000588 | Amines |
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| Catecholamines |
| Drug |
catecholamine restrictive anesthesia protocol |
|
|
| D009930 |
| Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |