The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Perioperative Goal-Directed Therapy Based on Individualized Oxygen Balance on Outcomes During High-risk Cardiac Surgery:A Single Center, Prospective,Randomized,Controlled,Double Blinded Study.

Conditions
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Cardiac Disease, High Risk Sex

Intervention / Treatment
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* Procedure: mean artery pressure
* Procedure: bispectral index
* Procedure: Brain oxygen saturation
* Other: Controlled


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent; Selective cardiac surgery and general anesthesia patients; Age 18-90 yrs; Anesthesia Society of American (ASA) Scale II-IV European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50% Exclusion Criteria: Preoperative cardiac ejection fraction<30 %; History of anesthesia awareness; History or anticipation of difficult intubation; Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia; long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Goal-Directed Therapy<br>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. | Procedure: mean artery pressure<br>* mean artery pressure declined with less than 20% of baseline<br>Procedure: bispectral index<br>* BIS 45-60 before and after CPB; and BIS 40-45 during CPB<br>* Other names: BIS;Procedure: Brain oxygen saturation<br>* Brain oxygen saturation declined with less than 20% of baseline<br>|
| Sham Comparator: Controlled<br>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. | Other: Controlled<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen dynamics, Prognosis