NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03715712
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2018
Completion date	October 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03255187` - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution	N/A
Completed	`NCT05997303` - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT03918486` - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed	`NCT03410342` - The Effects of Types of Fruits and Vegetables on Vascular Function	N/A
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Not yet recruiting	`NCT04087070` - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed	`NCT03294928` - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers	N/A
Completed	`NCT03859934` - Metabolic Effects of Melatonin Treatment	Phase 1
Completed	`NCT03997461` - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device	N/A
Completed	`NCT03290716` - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China	N/A
Recruiting	`NCT05196048` - Blood Pressure Sensor of Watch-type Device With ECG Technology
Recruiting	`NCT06460233` - Blood Pressure Changes After Bariatric Surgery
Terminated	`NCT03325933` - Resistance Training and Cardiometabolic Health	N/A
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Completed	`NCT02924454` - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.	Phase 4
Completed	`NCT02451059` - Reducing Socioeconomic Disparities in Health at Pediatric Visits	N/A
Active, not recruiting	`NCT02670967` - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials	N/A
Completed	`NCT02239744` - Intervention Study on the Health Impact of Air Filters in Chinese Adults	N/A
Completed	`NCT02271633` - Nitrate Supplementation; Source	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.