NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715712
• Other study ID #: NORMALIZE
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Pressure
• Non-cardiac Surgery
• Perioperative Myocardial Injury

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