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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Mustafa Aydemir, MD
- Número de telefone: +903323105000
- E-mail: drmustafaaydemir02@gmail.com
Locais de estudo
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Konya, Turquia (Türkiye), 42200
- Recrutamento
- Konya City Hospital
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Contato:
- Mustafa Aydemir
- Número de telefone: +903323105000
- E-mail: drmustafaaydemir02@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Post-Induction Hypotension
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Diagnostic Performance of EASIX Score for Post-Induction Hypotension
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mustafa Aydemir, MD, Konya City Hospital
Publicações e links úteis
Publicações Gerais
- 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.
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Outros números de identificação do estudo
- PIXEL-EASIX-PIH-2026
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