NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

Study Overview
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Brief Summary
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This study compares the effect of individualized vs standard blood pressure management on postoperative myocardial injury in high-risk patients undergoing non-cardiac surgery by measuring the hs-cTnT levels. Continuous norepinephrine infusion is used to target a mean pressure of greater than 65mmHg and a systolic pressure less than 160mmHg in the standardized group while the target is 20% within the ward blood pressure in the individualized group. The pre- and postoperative hs-cTnT levels to detect myocardial injury are compared between the two groups.

Detailed Description
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Managing the blood pressure preoperatively is important in high-risk patients because hypotension can lead to perioperative myocardial injury. It has been reported that a systolic pressure of less than 50-55mmHg or greater than 40% decrease can lead to cardiac complications. The mechanism of hypotension leading to postoperative myocardial injury is due to hypoperfusion and ischemic reperfusion injury. In this randomized controlled study, the blood pressure for participants in the standardized group is maintained as follows: mean blood pressure greater than 65mmHg and systolic blood pressure less than 160mmHg. The individualized group participants' blood pressure is maintained at a target of 20% within the preoperative ward blood pressure. Anesthesia and intraoperative management are the same in both groups to target a bispectral index level of 50. In order to quantitatively measure the myocardial injury, high sensitive cardiac troponin T (hs-cTnT) will be measured pre- and postoperatively. A level greater than 14ng/dl has been reported to be associated with myocardial injury and mortality. The objective of this study is to show that the standardized protocol of maintaining a mean pressure greater than 65mmHg is non inferior to the individualized management in terms of postoperative myocardial injury.

Official Title
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Comparison of Individualized vs Standard Blood Pressure Target on the Postoperative Myocardial Injury in High Risk Patients Undergoing Non-cardiac Surgery- a Randomized Non-inferiority Trial

Conditions
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Perioperative Myocardial Injury, Blood Pressure, Non-cardiac Surgery

Intervention / Treatment
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* Other: standardized blood pressure management
* Other: Individualized blood pressure management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for general or urologic surgeries under general anesthesia at Seoul National University Hospital high-risk patients with a revised cardiac risk index of at least 2 points or more Exclusion Criteria: severely uncontrolled hypertension (systolic blood pressure ≥ 180mmHg or mean blood pressure ≥ 110) severely uncontrolled hypotension (systolic blood pressure < 80mmHg) arrhythmias with symptoms or use of pacemaker transplantation surgery acute or decompensated heart failure acute coronary syndrome sepsis end stage renal disease (GFR <30ml/min/1.73m2) contraindications of norepinephrine infusion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard<br>Standardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg | Other: standardized blood pressure management<br>* Standardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion<br>|
| Active Comparator: Individualized<br>Individualized blood pressure management of 20% within the preoperative ward blood pressure | Other: Individualized blood pressure management<br>* Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of postoperative myocardial injury | the change of hs-cTnT levels | baseline and postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital LOS | hospital length of stay | 1 month | 
| ICU LOS | ICU length of stay | 1 month | 
| in hospital mortality | in hospital mortality | 1 month | 
| Amount of norepinephrine used | total amount of norepinephrine used | intraoperative | 
| intraoperative vital signs | blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index | intraoperative | 
| acute myocardial complications | chest pain, dyspnea, edema, acute coronary syndrome | 1 month | 
| acute kidney injury | serum creatinine increase and urine output | postoperative 48 hours |