Adrenergic Beta-Receptor Blockader, Cardiomyopathy, Post-surgical, Troponin Levels
Conditions
Brief summary
Perioperative cardiac adverse events \[heart injuries caused by general anesthesia and surgical procedures\] are a significant public health issue, with more than 60,000 deaths per annum in patients having surgery for non-heart related issues. There are virtually no evidence-based medical strategies for effective prevention of these events. Preoperative drug treatment with beta blockade drugs used for high blood pressure, perioperative therapy with lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high blood pressure, and aspirin have all been investigated as potential mitigating treatments, but without positive clinical outcomes and, in some cases, creating more hemodynamic instabilities that result in heart injury. In light of this, investigators propose to evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately after surgery and to assess the value of high-sensitivity cardiac troponin level testing of the blood in predicting those patients who would benefit most from perioperative beta blocker therapy.
Interventions
DRUGmetoprolol
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 years * American Society of Anesthesiologists (ASA) risk status III-IV * Revised Cardiac Risk Index ≥2 * β-blocker naïve (not having received β-blocker within 30 days prior to surgery) * Previously diagnosed coronary artery disease (CAD) or at high risk for CAD: * History of peripheral vascular disease, or * Diabetes and currently on oral anti-diabetic drug or insulin therapy, or * Chronic renal failure (eGFR \<30 m/min) * Major non-cardiac surgery under general anesthesia
Exclusion criteria
* History of stroke * Heart rate \<55bpm * Heart failure * Second or third degree AV block without pacemaker * Active asthma or COPD * Anemia \[Hb\<9g/dL\] * Allergy to beta-blockade drugs * Hemodynamic instability * Uncontrolled hemorrhage * Unwilling or unable to give consent for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in hscTnI Values | Before surgery and Immediately after surgery (on the day of surgery) | Difference in hscTnI concentrations between preoperative clinic visit and day of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Postsurgical: 5mg metoprolol, IV, prior to extubation, every 5 minutes to achieve target heart rate of 65/min, up to 15mg; then 25mg metoprolol, oral, every 8 hours for 72 hours.
metoprolol | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Bradycardia/hypotension | 9 |
| Overall Study | PI unavailable | 1 |
| Overall Study | put on beta-blocker | 3 |
| Overall Study | Received epidural | 10 |
| Overall Study | Study paused | 8 |
| Overall Study | Surgery cancelled or time chaned | 13 |
| Overall Study | type of surgery | 1 |
| Overall Study | typ of surgery | 1 |
| Overall Study | Unknown history of CVA | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Difference in hscTnI Values
Difference in hscTnI concentrations between preoperative clinic visit and day of surgery
Time frame: Before surgery and Immediately after surgery (on the day of surgery)
Population: Only patients with complete hscTnI data were inlcuded
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment | Difference in hscTnI Values | Preoperative visit | 3.4 ng/L |
| Treatment | Difference in hscTnI Values | Day of surgery | 2.8 ng/L |