NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

Not Applicable

Completed

• Conditions: Perioperative Myocardial Injury; Blood Pressure; Non-cardiac Surgery
• Interventions: Other: standardized blood pressure management; Other: Individualized blood pressure management

• Registration Number: NCT03715712
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-21
• Study First Posted: 2018-10-23
• Study Start: 2018-11-01
• Primary Completion: 2023-05-28
• Study Completion: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	standardized blood pressure management	Standardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg
Individualized	Individualized blood pressure management	Individualized blood pressure management of 20% within the preoperative ward blood pressure

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative myocardial injury	baseline and postoperative day 1	the change of hs-cTnT levels

Secondary Outcome Measures

Name	Time	Method
hospital LOS	1 month	hospital length of stay
ICU LOS	1 month	ICU length of stay
acute myocardial complications	1 month	chest pain, dyspnea, edema, acute coronary syndrome
intraoperative vital signs	intraoperative	blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index
Amount of norepinephrine used	intraoperative	total amount of norepinephrine used
acute kidney injury	postoperative 48 hours	serum creatinine increase and urine output
in hospital mortality	1 month	in hospital mortality

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of