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Completed

NCT Number: NCT03715712

NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standardized blood pressure management

Other

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

Other

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

Primary outcomes

  1. Occurrence of postoperative myocardial injury

    Time frame: baseline and postoperative day 1

    the change of hs-cTnT levels

Secondary outcomes

  1. hospital LOS

    Time frame: 1 month

    hospital length of stay

  2. ICU LOS

    Time frame: 1 month

    ICU length of stay

  3. in hospital mortality

    Time frame: 1 month

    in hospital mortality

  4. Amount of norepinephrine used

    Time frame: intraoperative

    total amount of norepinephrine used

  5. intraoperative vital signs

    Time frame: intraoperative

    blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index

  6. acute myocardial complications

    Time frame: 1 month

    chest pain, dyspnea, edema, acute coronary syndrome

  7. acute kidney injury

    Time frame: postoperative 48 hours

    serum creatinine increase and urine output

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 23, 2018
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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