Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients: the BOTTOMLINE-CS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,960
- 试验地点
- 1
- 主要终点
- Composite complication
研究概览
简要总结
The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.
详细描述
Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model.
Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 60 years scheduled for elective off-pump CABG.
排除标准
- •Inability or refusal to provide consent of participation
- •Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min))
- •Preoperative requirement of external cardiac assist device
- •Urgent or emergent surgery
- •Patients expected to die within 30 days of randomization
研究组 & 干预措施
Multisite tissue oxygenation monitoring-guided care
Details are as follows. • Monitoring: SctO2 monitored using two probes placed on left and right forehead. SstO2 monitored using one probe placed over the forearm brachioradialis muscle on the arm not used for non-invasive blood pressure monitoring.
• Baseline: The first baseline is measured 12-48 hours before surgery, with the patient supine, awake, calm, eyes closed, and breathing room air or oxygen that is equivalent to the home oxygen rate for patients using home oxygen.
- Goals: Maintain both SctO2 and SstO2 within 90-110% of the baseline level.
- Trigger of intervention: SctO2/SstO2 outside of the 90-110% baseline range.
- Diagnosis:
- Care team: The caregivers providing SctO2/SstO2-guided care will be trained and given the opportunity to use the intervention protocol in at least 20 patients before the formal study.
- Treatments: Refer to the algorithm to restore SctO2/SstO2 within 90-110% baseline range.
干预措施: Multisite tissue oxygenation-guided care (Other)
Usual care
Patients in the control group will be managed by clinical staff according to usual care. Patients in this group will be monitored using the same tissue oximeter used in the intervention group; however, the screen will be covered by an opaque cloth to prohibit the care givers seeing the monitoring data. The same baseline measurements will be performed in patients allocated to the usual care group.
干预措施: Usual care (Other)
结局指标
主要结局
Composite complication
时间窗: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days (individual components may vary)
The primary outcome is a collapsed (one or more) composite of the following complications with a Clavien-Dindo grade II or greater arising within 30 days of randomization (randomization and surgery are performed on the same day). The patient is regarded as having the event of composite complications if any of the following complications occur (i.e., yes); otherwise, the patient is regarded as not having the event of composite complications. The percentage of patients having the event of composite complications will be used in the primary analysis. * Brain complications (delirium, cognition decline, stroke); * Cardiac complications (non-fatal cardiac arrest, myocardial injury, heart failure, new-onset symptomatic ventricular arrhythmia); * Respiratory failure; * Renal complications (AKI stages II and III); * Infectious complications; * Death.
次要结局
- Perioperative stroke(Stroke will be assessed from the day of surgery throughout postoperative day 30)
- Atrial fibrillation(from the day of surgery until postoperative day 30)
- Length of hospital stay(from the day of surgery (day 0) until hospital discharge or until day 30, whichever occurs first)
- Renal complications (one component of the primary outcome)(from the postoperative day 1 until postoperative day 7 for a total of 7 days)
- Postoperative delirium(from postoperative day 1 throughout postoperative day 5)
- Postoperative cognitive decline(Assessed before surgery, on postoperative day 5 and 30)
- Respiratory failure (one component of the primary outcome)(from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days)
- Cardiac complications (one component of the primary outcome)(from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days)
- Infectious complications (one component of the primary outcome)(from postoperative day 1 until postoperative day 30 for a total of 30 days)