Hypotension Prediction With HPI Algorithm During Decessed-donor Kidney Transplant: an Explorative, Monocentric, RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Intra-operative hypotension time
研究概览
简要总结
HPI monitoring and the adoption of therapeutic interventions before hypotension occurs should be ensure a shorter time of intra-operative hypotension (MAP < 65 mmHg) during deceased-donor kidney transplant surgery. The control group is represented by patients undergoing the same surgical procedure with hemodynamic monitoring with invasive blood pressure monitoring which represents the gold standard for this surgery. HPI monitoring has not yet been investigated during this surgery.
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
- •First single or double kidney transplant from a cadaveric donor;
- •ASA Class III-IV;
- •Signature of informed consent.
排除标准
- •Patient with atrial fibrillation rhythm or high frequency tachyarrhythmias;
- •Severe valvulopathies;
- •Combined single/double kidney-liver-transplant;
- •Patients in whom the need for monitoring would still be expected advanced, invasive or minimally invasive hemodynamic, regardless of the allocation to the study group;
- •Inclusion in another study.
结局指标
主要结局
Intra-operative hypotension time
时间窗: From 20 minutes after anaesthesia induction to the end of surgery (intra-operative)
Hypotension (MAP \< 65 mmHg) time relative to the range from 20 minutes after induction to the end of surgery
次要结局
- Intensive Care Unit Length of Stay(First 30 post-operative days after surgery (post-operative))
- Major Adverse Cardiovascular Events (MACE)(First 5 post-operative days after surgery (post-operative))
- Intra-operative severe hypotension time(From 20 minutes after anaesthesia induction to the end of surgery (intra-operative))
- Hospital mortality(First 30 post-operative days after surgery (post-operative))
- Hospital Length of Stay(First 30 post-operative days after surgery (post-operative))
- Post-operative delirium(First 5 post-operative days)
- Post-operative hypotension time(From the end of surgery to the first 12 hours after surgery (post-operative))
- Delayed Graft Function (DGF)(First 7 post-operative days (post-operative))
- Graft survival(30 days after transplantation)
研究者
Cristiana Laici, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna