Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Serum neurofilament light chain concentration
研究概览
简要总结
The SHIELD trial is a single-center, randomized, controlled, parallel-group, single-blinded clinical trial investigating whether performing RIPC one day before surgery-compared to not performing RIPC-reduces postoperative neuronal injury, as reflected by the maximum serum NfL concentration within the first 2 postoperative days, in non-cardiac surgery patients at risk for postoperative delirium.
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
- Single (Care Provider)
盲法说明
Clinicians involved in perioperative care and laboratory staff will be blinded to group allocation.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (≥50 years) scheduled for elective non-cardiac surgery with general anesthesia
- •patients at risk for postoperative delirium, defined as the presence of ≥2 of the following established risk factors: age ≥65 years, American Society of Anesthesiologists physical status classification of ≥III, Charlson Comorbidity, planned surgical duration >180 minutes, polypharmacy (regular intake of more than five medications), symptoms of depression (Patient Health Questionnaire-9 ≥10 points)
排除标准
- •patients in whom RIPC cannot be safely applied due to relevant peripheral arterial disease (defined as Fontaine stage ≥II), lymphedema, recent upper-arm surgery, trauma, or skin lesions at the arm
- •patients with acute coronary syndrome (within the past month)
- •patients with surgery in the previous month
- •patients with intracranial surgery
- •patients with pre-existing delirium
- •patients with severe cognitive impairment preventing reliable delirium assessment
- •patients with current treatment with sulfonamides due to potential interference with ischemic preconditioning mechanisms
- •patients with previous participation in the SHIELD trial
研究组 & 干预措施
RIPC group
In patients assigned to the RIPC group, we will perform RIPC on the day before surgery. If surgery is postponed, RIPC will be repeated on the day before the rescheduled surgery. RIPC will be performed with 3 cycles of upper-arm ischemia for 5 minutes followed by reperfusion for 5 minutes, using a blood pressure cuff inflated to 200 mmHg or to 50 mmHg above the systolic arterial pressure, whichever is higher.
干预措施: Remote ischemic preconditioning (Other)
No-RIPC group
Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed. No sham procedure will be applied, given the objective nature of the primary outcome.
干预措施: Routine care (Other)
结局指标
主要结局
Serum neurofilament light chain concentration
时间窗: Within the first 2 postoperative days
Maximum serum NfL concentration
次要结局
- Serum neuron-specific enolase concentration(Postoperative day 1)
- Change in serum neurofilament light chain concentrations(Baseline (before surgery) and within the first 2 postoperative days)
- Change in serum neuron-specific enolase concentrations(Baseline (before surgery) and the first postoperative day)
研究者
Dr. Alina Bergholz
Principal Investigator
University of Hamburg-Eppendorf