EASIX Score and Post-Induction Hypotension in Frail Patients Undergoing Non-Cardiac Surgery (PIXEL)
Evaluation of the Relationship Between Endothelial Activation and Stress Index (EASIX) and Post-Induction Hypotension in Frail Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study
Post-induction hypotension (PIH) is a common and clinically significant hemodynamic complication following general anesthesia induction. Frail patients are particularly vulnerable due to impaired vascular reactivity and endothelial dysfunction. The Endothelial Activation and Stress Index (EASIX), calculated from routine laboratory parameters (LDH, creatinine, and platelet count), may serve as a preoperative biomarker to identify patients at risk for PIH.
This prospective observational cohort study aims to evaluate the association between preoperative EASIX score and the occurrence of post-induction hypotension in frail patients undergoing elective non-cardiac surgery under general anesthesia. A total of 160 patients with a Clinical Frailty Scale (CFS) score of 4 or above will be enrolled. Mean arterial pressure will be measured every 2 minutes for the first 15 minutes after induction. PIH is defined as MAP below 65 mmHg and/or a decrease of 20% or more from baseline.
研究概览
详细说明
EASIX is calculated as: LDH (U/L) × Creatinine (mg/dL) / Platelet count (10⁹/L), using routine preoperative laboratory values obtained within 24 hours before surgery.
All patients will receive a standardized anesthesia induction protocol: midazolam 0.05 mg/kg, fentanyl 2 mcg/kg, propofol 2 mg/kg, and rocuronium 0.6 mg/kg intravenously, followed by endotracheal intubation after 2 minutes of mask ventilation. Anesthesia maintenance will consist of 2% sevoflurane and remifentanil 0.2 mcg/kg/min infusion.
The primary outcome is the occurrence of PIH within the first 15 minutes after induction. Secondary outcomes include the diagnostic performance of EASIX (ROC-AUC analysis) and the interaction between frailty severity and EASIX on PIH development. Multivariable logistic regression will be performed adjusting for age, sex, ASA classification, baseline MAP, antihypertensive medication use, fasting duration, and induction agent doses.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Mustafa Aydemir, MD
- 电话号码：+903323105000
- 邮箱：drmustafaaydemir02@gmail.com
学习地点
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Konya、土耳其（türkiye）、42200
- 招聘中
- Konya City Hospital
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接触：
- Mustafa Aydemir
- 电话号码：+903323105000
- 邮箱：drmustafaaydemir02@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective non-cardiac surgery under general anesthesia
- Clinical Frailty Scale (CFS) score of 4 or above
- Available routine preoperative laboratory values (LDH, creatinine, platelet count) within 24 hours before surgery
Exclusion Criteria:
- Cardiac surgery
- Emergency surgery
- Preoperative vasopressor infusion
- Severe hematological disease
- Missing laboratory data required for EASIX calculation
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Frail Patients Undergoing Non-Cardiac Surgery
Adult patients aged 18 years or older with a Clinical Frailty Scale (CFS) score of 4 or above, scheduled for elective non-cardiac surgery under general anesthesia at Konya City Hospital.
Preoperative EASIX score will be calculated from routine laboratory values (LDH, creatinine, platelet count) obtained within 24 hours before surgery.
Post-induction hemodynamic data will be collected for the first 15 minutes after anesthesia induction.
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Preoperative Endothelial Activation and Stress Index (EASIX) score calculated from routine laboratory parameters obtained within 24 hours before surgery.
Formula: LDH (U/L) × Creatinine (mg/dL) / Platelet count (10⁹/L).
No additional blood sampling is performed; only existing routine preoperative laboratory values are used.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Incidence of Post-Induction Hypotension
大体时间：Within the first 15 minutes after anesthesia induction
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Occurrence of MAP below 65 mmHg and/or a decrease of 20% or more from baseline mean arterial pressure, measured every 2 minutes for the first 15 minutes after anesthesia induction, before surgical incision.
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Within the first 15 minutes after anesthesia induction
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Diagnostic Performance of EASIX Score for Post-Induction Hypotension
大体时间：Preoperative assessment within 24 hours before surgery
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Area under the receiver operating characteristic curve (ROC-AUC) of preoperative EASIX score for predicting post-induction hypotension.
EASIX is calculated as: LDH (U/L) × Creatinine (mg/dL) / Platelet count (10^9/L).
ROC-AUC ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination); higher values indicate better predictive performance.
Optimal cut-off value will be determined by Youden index.
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Preoperative assessment within 24 hours before surgery
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Interaction Between Frailty Severity and EASIX on Post-Induction Hypotension
大体时间：Within the first 15 minutes after anesthesia induction
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Effect modification of Clinical Frailty Scale (CFS) score on the association between preoperative EASIX score and post-induction hypotension, evaluated by multivariable logistic regression with interaction term.
CFS ranges from 1 (very fit) to 9 (terminally ill); higher scores indicate greater frailty.
EASIX is a continuous score with no fixed range; higher values indicate greater endothelial stress.
Results will be reported as odds ratios with 95% confidence intervals.
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Within the first 15 minutes after anesthesia induction
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合作者和调查者
调查人员
- 首席研究员：Mustafa Aydemir, MD、Konya City Hospital
出版物和有用的链接
一般刊物
- Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
- Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
- Luft T, Benner A, Jodele S, Dandoy CE, Storb R, Gooley T, Sandmaier BM, Becker N, Radujkovic A, Dreger P, Penack O. EASIX in patients with acute graft-versus-host disease: a retrospective cohort analysis. Lancet Haematol. 2017 Sep;4(9):e414-e423. doi: 10.1016/S2352-3026(17)30108-4. Epub 2017 Jul 18.
- Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PIXEL-EASIX-PIH-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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