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Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state [intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) ]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Goal-Directed Therapy | Experimental | The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline. |
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| Controlled | Sham Comparator | no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mean artery pressure | Procedure | mean artery pressure declined with less than 20% of baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis) | Number of Participants with major complications extracted after 30-day follow-up | 30-day after surgery |
| 30-day mortality | Data for duration of postoperative 30-day all-cause mortality | 30-day after surgery |
| The change of incidence of postoperative delirium | Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium | The 1,2,3 day after surgery |
| 1,3,5-year mortality | Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up | 1,3,5-year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative hospital stay | Data for duration of postoperative hospital stay is extracted after 30-day follow-up | 30-day after surgery |
| The change of incidence of postoperative cognition dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32889413 | Derived | Cheng XQ, Zhang JY, Wu H, Zuo YM, Tang LL, Zhao Q, Gu EW. Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial. J Clin Anesth. 2020 Dec;67:110032. doi: 10.1016/j.jclinane.2020.110032. Epub 2020 Sep 1. |
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Interventional group:MAP declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.
Control group：no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
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Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal
| bispectral index | Procedure | BIS 45-60 before and after CPB; and BIS 40-45 during CPB |
|
|
| Brain oxygen saturation | Procedure | Brain oxygen saturation declined with less than 20% of baseline |
|
| Controlled | Other | receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr. |
|
The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively.
| 1 day before surgery, the 3,7 day after the surgery |
| The occurrence of cardiovascular events | Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up | 30-day after surgery |
| The incidence of any adverse events | Including kidney or brain related adverse events 30-day after surgery | 30-day after surgery |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D047568 | Unsafe Sex |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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