RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Troponin
研究概览
简要总结
This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
详细描述
Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years.
- •Surgery type: Major Abdominal Oncologic Surgery
- •Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days
排除标准
- •Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines
- •Patients with Chronic Kidney Disease Stage IV or V
- •Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions)
- •No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30
研究组 & 干预措施
RESIPI
Intraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical).
干预措施: RESIPI Management Strategy (Procedure)
Standard intraoperative care- no interventions
Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions
干预措施: No intervention (Other)
结局指标
主要结局
Troponin
时间窗: Post Op day 1
Change in troponin (\>=0.04%)
B-typer Natriuretic Peptide (BNP)
时间窗: Post Op day 1
Change in BNP (\>250 ng/ml)
次要结局
- Days at home in first 30 days(30 days post operative)
- Hospital length of stay(Approximately 3-5 days)
- Readmission rate (Emergency room or hospital)(30 days post operative)
- All-cause mortality(30 days post op)
- Major cardiac events(30 days post op)
- Total hospital cost(30 days post operative)
- Return to operating room(30 days post operative)
- Occurrence of significant medical events(30 days post operative)
研究者
Matthew McEvoy
Professor
Vanderbilt University Medical Center