NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Perioperative Myocardial Injury; Non-cardiac Surgery
• Intervention / Treatment: Other: standardized blood pressure management; Other: Individualized blood pressure management

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyung-Chul Lee, Ph.D.; Phone Number: 82-2-2072-2467; Email: lucid80@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard; 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; Standardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion
Active Comparator: Individualized; Individualized blood pressure management of 20% within the preoperative ward blood pressure	Other: Individualized blood pressure management; Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chul-Woo Jung, Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 28, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NORMALIZE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No