The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period.
研究概览
简要总结
The purpose of this study is to evaluate whether the administration of 5 ml/kg of colloid solution prior to anesthesia induction, compared with 5 ml/kg of lactated Ringer's solution, can reduce hemodynamic fluctuations during the induction period (defined as the first 15 minutes after induction) in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 years;
- •Patients scheduled to undergo elective TAVR under general anesthesia;
排除标准
- •Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy;
- •Severe cardiac dysfunction (ejection fraction[EF] < 35%);
- •Severe renal dysfunction (creatinine > 132 μg/L and/or requiring renal replacement therapy);
- •Morbid obesity (body mass index[BMI] > 37.5 kg/m² or > 32.5 kg/m² with metabolic diseases);
- •Severe hepatic dysfunction ;
- •Severe electrolyte disturbances ;
- •Patients with preoperative intracranial hypertension requiring dehydration therapy;
- •Expected postoperative hospital stay < 24 hours;
- •Patients scheduled for multiple surgeries during this hospitalization.
研究组 & 干预措施
Colloid
5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection.
干预措施: Hydroxyethyl starch 130/0.4 (Drug)
Crystalloid
5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.
干预措施: Lactate Ringer's Solution (Drug)
结局指标
主要结局
The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period.
时间窗: induction period, at an average of 15 minutes
The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5…15), and ΔX is the time interval between measurements.
次要结局
- Incidence of post-induction hemodynamic instability, defined as arterial pressure (MAP)< 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction.(15 minutes after induction)
- Sequential Organ Failure Assessment(SOFA )score on the first postoperative day(The first postoperative day, at 24 hours after surgery)
- Intraoperative use of vasoactive drugs.(Intraoperative period, at an average of 2 hours)
- Length of hospital stay.(The duration of the patient's hospitalization after the initial surgery, at an average of 5 days.)
- Proportion of patients admitted to the intensive care unit (ICU) after surgery(During the postoperative period prior to discharge (at an average of 5 days))
- In-hospital all-cause mortality(During the postoperative period prior to discharge (at an average of 5 days))
- All-cause mortality within 30 days postoperatively(30 days after surgery)
- Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period(30 days after surgery)
研究者
Zhihong LU
associate professor
Air Force Military Medical University, China