Clinical trial NCT03715712: NORepinephrine-Maintaining-individuaALIZEd Blood Pressure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Myocardial Injury
Blood Pressure
Non-cardiac Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 420
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Occurrence of postoperative myocardial injury
timeFrame: baseline and postoperative day 1
Secondary outcomes:
measure: hospital LOS
timeFrame: 1 month
measure: ICU LOS
timeFrame: 1 month
measure: in hospital mortality
timeFrame: 1 month
measure: Amount of norepinephrine used
timeFrame: intraoperative
measure: intraoperative vital signs
timeFrame: intraoperative
measure: acute myocardial complications
timeFrame: 1 month
measure: acute kidney injury
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: