NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

NCT ID: NCT03715712

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2023-10-01

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.

Conditions

Perioperative Myocardial Injury; Blood Pressure; Non-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standard

Standardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg

Group Type: EXPERIMENTAL

standardized blood pressure management

Intervention Type: OTHER

Standardized blood pressure management of a mean blood pressure \> 65mmHg and a systolic blood pressure of \< 160mmHg using norepinephrine continuous infusion

Individualized

Individualized blood pressure management of 20% within the preoperative ward blood pressure

Group Type: ACTIVE_COMPARATOR

Individualized blood pressure management

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Individualized blood pressure management

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chul-Woo Jung

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chul-Woo Jung, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

NORMALIZE

Identifier Type: -

Identifier Source: org_study_id