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NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

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ClinicalTrials.gov Identifier: NCT03715712
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Perioperative Myocardial Injury Blood Pressure Non-cardiac Surgery Other: standardized blood pressure management Other: Individualized blood pressure management Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 31, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of postoperative myocardial injury [ Time Frame: baseline and postoperative day 1 ]
    the change of hs-cTnT levels


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715712


Contacts
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Contact: Hyung-Chul Lee, Ph.D. 82-2-2072-2467 lucid80@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul-Woo Jung, MD. PhD    82-2-2072-2467    spss@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Chul-Woo Jung, Ph.D. Seoul National University Hospital
More Information
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Responsible Party: Chul-Woo Jung, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03715712    
Other Study ID Numbers: NORMALIZE
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No