EASIX Score and Post-Induction Hypotension in Frail Patients Undergoing Non-Cardiac Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое EASIX Score Assessment
  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.

Первичные конечные точки

• Incidence of Post-Induction Hypotension [Срок оценки: Within the first 15 minutes after anesthesia induction]

Вторичные конечные точки (2)

• Diagnostic Performance of EASIX Score for Post-Induction Hypotension [Срок оценки: Preoperative assessment within 24 hours before surgery]
• Interaction Between Frailty Severity and EASIX on Post-Induction Hypotension [Срок оценки: Within the first 15 minutes after anesthesia induction]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Cardiac surgery
• Emergency surgery
• Preoperative vasopressor infusion
• Severe hematological disease
• Missing laboratory data required for EASIX calculation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Konya City Hospital — Konya

Публикации

• 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. PMID 28974066
• 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. PMID 30236233
• 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. PMID 30144029
• 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. PMID 16129869
• 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. PMID 28733186

Идентификаторы

NCT: NCT07642765 · PIXEL-EASIX-PIH-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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