BRS and Outcomes in Cardiothoracic Surgery

Atrial Fibrillation Clinical Trial

Official title:

Role of Preoperative Baroreflex Sensitivity on Major Outcomes After Cardiothoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243279
• Other study ID #: Pro00083136
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether baroreceptor sensitivity (the ability of your body to change your heart rate and/or blood pressure in response to a situation) has any effect on how likely you are to suffer certain events after heart or lung surgery. The postoperative events that the investigators will be studying are pain after surgery, atrial fibrillation (an irregular heart rhythm), and cognitive dysfunction (a decline in mental abilities).

Description:

The purpose of this study is to determine if preoperative baroreceptor sensitivity (BRS) correlates with major outcomes after cardiac and thoracic surgery, including acute and chronic pain, atrial arrhythmias, and cognitive function. To test this hypothesis, approximately 95 patients will be enrolled, and spontaneous baroreceptor sensitivity will be measured prior to surgery as well as immediately postoperatively. Outcomes will include acute pain using the numeric rating scale, Brief Pain Inventory, and Gracely Box Scale administered preoperatively, on postoperative days 1 and 2 and by phone at 6-weeks postoperatively. Chronic pain will be assessed at 6-month follow-up visit via hyperalgesia testing using Von Frey filaments. Postoperative atrial arrhythmias will be assessed by review of postoperative telemetry, the electronic medical record, and ECG performed prior to discharge. Finally, cognitive function will be assess via Mini-Mental State examination administered preoperative and at the 6-month follow-up visit. Association between BRS and the outcomes of interest will be tested with regression models adjusted for appropriate covariates. Significance threshold alpha will be adjusted for the number of statistical tests using the Bonferroni correction. Our hypothesis is that patients with impaired preoperative BRS will have an increased incidence of acute and chronic postoperative pain, atrial fibrillation, and cognitive decline after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 31, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >= 18 years of age

• Undergoing cardiac (coronary artery bypass grafting [CABG], CABG + valve, or valve only) or thoracic (video-assisted thoracoscopic [VATS] approach to lobectomy) surgery

Exclusion Criteria:

• Any preexisting pain condition (defined as pain of >=3 months duration prior to enrollment)

• Pain at the time of enrollment interview

• Need for preoperative analgesics

• Preexisting chronic or paroxysmal atrial fibrillation

• Preexisting atrial or ventricular arrhythmia

• Need for preoperative anti-arrhythmic medication

• History of symptomatic cerebrovascular disease (e.g., prior stroke) with residual deficits

• Alcoholism (>2 drinks/day)

• Psychiatric illness (any clinical diagnosis requiring therapy)

• Drug abuse (any illicit drug use in the preceding 3 months before surgery)

• Hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)

• Severe pulmonary insufficiency (home oxygen)

• Renal failure (serum creatinine >2.0 mg/dL)

• Non-English speaking

• Unable to read

• Participants who score <24 on baseline Mini Mental State examination

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cognitive Dysfunction
• Pain, Postoperative

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min
Secondary	Postoperative day (POD) 1 baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min
Secondary	POD 2 baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	30 min
Secondary	6 month baroreflex sensitivity	Non-invasive BRS testing with BIOPAC MP160	6 months
Secondary	Acute postoperative pain as assessed by the numeric rating scale (NRS) - 24h	Median NRS pain score in the first 24h after surgery	24 hours
Secondary	Acute postoperative pain as assessed by the numeric rating scale (NRS) - 48h	Median NRS pain score in the second 24h after surgery	48 hours
Secondary	Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD1	GBS survey on POD 1	15 min
Secondary	Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - POD2	GBS survey on POD 2	15 min
Secondary	Acute postoperative pain as assessed by the Gracely Box Scale (GBS) - 6 mo	GBS survey at 6 month follow-up visit	6 months
Secondary	Chronic pain as assessed by the change in Brief Pain Inventory score	Change from baseline to 6 months postoperatively	Baseline, 6 months
Secondary	Hyperalgesia	Nociceptive threshold as assessed by Von Frey filament testing at 6 month follow-up	6 months
Secondary	Area of hyperalgesia or allodynia	Area surrounding operative incision as assessed by Von Frey filament testing at 6 month follow-up	6 months
Secondary	Postoperative atrial fibrillation	Chart review assessment of the occurrence of postoperative atrial fibrillation during hospitalization and up to 6 weeks postoperatively	6 weeks
Secondary	Postoperative cognitive change	Change from baseline to 6 months in the Mini Mental Status Exam score	Baseline, 6 months
Secondary	Baseline psychological distress	As assessed by the Brief Symptom Inventory-18	15 min
Secondary	6 month psychological distress	As assessed by the Brief Symptom Inventory-18	6 months
Secondary	Baseline frailty	As assessed by the Modified Frailty Index	10 min