Blood Pressure Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 420 |
Est. completion date | October 1, 2023 |
Est. primary completion date | May 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of postoperative myocardial injury | the change of hs-cTnT levels | baseline and postoperative day 1 | |
Secondary | hospital LOS | hospital length of stay | 1 month | |
Secondary | ICU LOS | ICU length of stay | 1 month | |
Secondary | in hospital mortality | in hospital mortality | 1 month | |
Secondary | Amount of norepinephrine used | total amount of norepinephrine used | intraoperative | |
Secondary | intraoperative vital signs | blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index | intraoperative | |
Secondary | acute myocardial complications | chest pain, dyspnea, edema, acute coronary syndrome | 1 month | |
Secondary | acute kidney injury | serum creatinine increase and urine output | postoperative 48 hours |
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