Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 175
- 试验地点
- 3
- 主要终点
- Incidence of postoperative Right ventricular dysfunction (RVD)
研究概览
简要总结
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
详细描述
Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.
Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.
We will examine these questions in the following ways:
- With patients' permission, we will perform detailed ultrasound scans of the heart (echocardiography), and blood measurement of injury markers in 175 patients undergoing different types of major surgery. This will allow us to assess how common heart injury is (visible on scans of both sides of the heart), whether it makes any difference to a patient's outcome and whether it explains the changes seen in blood markers.
- We will ask 50 of these patients to undergo MRI scans of the heart pre- and post-operatively to allow us to identify evidence of injury resulting from heart inflammation around the time of surgery. Inflammation is common following surgery and occurs throughout a patient's body - we believe heart inflammation may be responsible for postoperative heart injury.
- In 10 of these patients, we will seek to obtain blood samples from vessels flowing into the heart (easily obtained from a simple blood sample) and from veins flowing out of the heart, obtained by passing a fine tube into the heart via blood vessels in a patient's neck under X-ray guidance. This will allow us to examine what happens to immune cells as they pass through the heart (i.e., are they activated by heart inflammation?) and better understand the meaning of the changes seen on MRI scans.
This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of informed consent
- •Age >18 years
- •Planned elective primary hip or knee joint replacement under spinal anaesthesia, major colorectal, major vascular surgery or surgery requiring one lung ventilation with or without lung resection
排除标准
- •On-going participation in any investigational research which could undermine the scientific basis of the study
- •Previous major surgery within three months prior to recruitment
- •Previous participation in the IMPRoVE study at any time
- •Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.
- •Additional exclusion criteria applicable to the T1 CMR sub-study includes:
- •Atrial fibrillation at baseline
- •Contraindication to cardiac magnetic resonance imaging (metal work in body etc)
- •Contraindication to IV Gadolinium: acute or chronic renal failure, allergy to contrast
结局指标
主要结局
Incidence of postoperative Right ventricular dysfunction (RVD)
时间窗: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
RVD diagnosed by transthoracic echocardiography, defined as: * 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%. * Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) \<16mm, S' Wave velocity at the tricuspid annulus \<10cm/s or tissue doppler RV index of myocardial performance \>0.55
Days alive and at home at 30 days postoperatively (DAH30)
时间窗: Day 30 postoperatively
DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.
次要结局
- Cardiac biomarkers(BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).)
- World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)(Preoperatively, and at day 30, day 90, and one year postoperatively.)
- EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)(Preoperatively, and at day 30, day 90, and one year postoperatively.)
- Pulmonary outcomes(Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).)
- Infection Outcomes(Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).)
- Fifteen-point Quality of Recovery Score (QoR-15)(Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).)
- Cardiovascular complications(Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).)
- Sequential Organ Failure Assessment (SOFA) Score(Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.)
- Incidence of postoperative left ventricular dysfunction (LVD)(Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function)
- Renal outcomes(Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).)
- Neurological outcomes(Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).)
研究者
Dr Ben Shelley
Honorary Professor/Consultant in Cardiothoracic Anaesthesia and Intensive Care
University of Glasgow