NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

NCT03715712 | Completed

• 1 other identifier: NORMALIZE
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Myocardial Injury; Blood Pressure; Non-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Occurrence of postoperative myocardial injury

  the change of hs-cTnT levels

  baseline and postoperative day 1

Secondary Outcomes (7)

• hospital LOS

  1 month

• ICU LOS

  1 month

• in hospital mortality

  1 month

• Amount of norepinephrine used

  intraoperative

• intraoperative vital signs

  intraoperative

Study Arms (2)

Standard

EXPERIMENTAL

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

Individualized

ACTIVE COMPARATOR

Individualized blood pressure management of 20% within the preoperative ward blood pressure

Other: Individualized blood pressure management

Interventions

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

Standard

Individualized blood pressure management OTHER

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

Individualized

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Chul-Woo Jung, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: May 28, 2023
• Study Completion: October 1, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

KR (1)