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The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making. |
|
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine | Drug | The Control group will be assessed using the standard care of traditional vital signs |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation) | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan W. Suttner, M.D. Ph.D. | Klinikum Ludwigshafen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigshafen | Ludwigshafen | RLP | 67063 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20156348 | Derived | Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15. |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D006895 | Hydroxyethyl Starch Derivatives |
| D009638 | Norepinephrine |
| D004280 | Dobutamine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Goal-directed hemodynamic therapy | Drug | Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine |
|
| Standard of care | Drug | Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine |
|
| D013213 |
| Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |