Blood Pressure, Non-cardiac Surgery, Perioperative Myocardial Injury
Conditions
Brief summary
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
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.
Interventions
OTHERstandardized blood pressure management
Standardized blood pressure management of a mean blood pressure \> 65mmHg and a systolic blood pressure of \< 160mmHg using norepinephrine continuous infusion
Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of postoperative myocardial injury | baseline and postoperative day 1 | the change of hs-cTnT levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU LOS | 1 month | ICU length of stay |
| in hospital mortality | 1 month | in hospital mortality |
| Amount of norepinephrine used | intraoperative | total amount of norepinephrine used |
| hospital LOS | 1 month | hospital length of stay |
| acute myocardial complications | 1 month | chest pain, dyspnea, edema, acute coronary syndrome |
| acute kidney injury | postoperative 48 hours | serum creatinine increase and urine output |
| intraoperative vital signs | intraoperative | blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index |
Countries
South Korea
Outcome results
None listed