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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03715712
Other study ID # NORMALIZE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date October 1, 2023

Study information

Verified date November 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
standardized 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
Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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