Perioperative Myocardial InjuryNCT03715712
NORepinephrine-Maintaining-individuaALIZEd Blood Pressure
A study testing standardized blood pressure management and Individualized blood pressure management in people with Perioperative Myocardial Injury and Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Perioperative Myocardial Injury, Blood Pressure, Non-cardiac Surgery
- What is being tested?
- standardized blood pressure management and Individualized blood pressure management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- sepsis
- end stage renal disease (GFR <30ml/min/1.73m2)
- contraindications of norepinephrine infusion
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- standardized blood pressure management, Individualized blood pressure management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized blood pressure managementOther
Standardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion
Individualized blood pressure managementOther
Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Standard | Experimental | Standardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg Receives: Other: standardized blood pressure management |
| Individualized | Active comparator | Individualized blood pressure management of 20% within the preoperative ward blood pressure Receives: Other: Individualized blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative myocardial injury
the change of hs-cTnT levels
Measured: baseline and postoperative day 1
Secondary outcomes (7)
hospital LOS
hospital length of stay
Measured: 1 month
ICU LOS
ICU length of stay
Measured: 1 month
in hospital mortality
in hospital mortality
Measured: 1 month
Amount of norepinephrine used
total amount of norepinephrine used
Measured: intraoperative
intraoperative vital signs
blood pressure, heart rate, ECG, stroke volume, stroke volume variation, bispectral index
Measured: intraoperative
acute myocardial complications
chest pain, dyspnea, edema, acute coronary syndrome
Measured: 1 month
acute kidney injury
serum creatinine increase and urine output
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion28 May 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715712
- Sponsor's protocol ID
- NORMALIZE
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2018
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03715712
- Acronym / sponsor ID
- NORMALIZE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Experimental | Other: standardized blood pressure managementStandardized blood pressure management with a target of mean blood pressure greater than 65mmHg and systolic blood pressure lower than 160mmHg |
| Individualized | Active comparator | Other: Individualized blood pressure managementIndividualized blood pressure management of 20% within the preoperative ward blood pressure |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized blood pressure managementStandardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion | Other | Standard |
| Individualized blood pressure managementIndividualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion | Other | Individualized |
Primary outcome
Occurrence of postoperative myocardial injury
Time frame: baseline and postoperative day 1
the change of hs-cTnT levels
7 secondary outcomes
hospital LOS
Time frame: 1 month
ICU LOS
Time frame: 1 month
in hospital mortality
Time frame: 1 month
Amount of norepinephrine used
Time frame: intraoperative
intraoperative vital signs
Time frame: intraoperative
acute myocardial complications
Time frame: 1 month
acute kidney injury
Time frame: postoperative 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul-Woo Jung, Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized blood pressure management and Individualized blood pressure management in people with Perioperative Myocardial Injury and Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of postoperative myocardial injury (time frame: baseline and postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.