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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mustafa Aydemir, MD
- 전화번호: +903323105000
- 이메일: drmustafaaydemir02@gmail.com
연구 장소
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Konya, 터키 (Türkiye), 42200
- Konya City Hospital
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연락하다:
- Mustafa Aydemir
- 전화번호: +903323105000
- 이메일: drmustafaaydemir02@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of Post-Induction Hypotension
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Performance of EASIX Score for Post-Induction Hypotension
기간: Preoperative assessment within 24 hours before surgery
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Area under the receiver operating characteristic curve (ROC-AUC) and optimal cut-off value of preoperative EASIX score for predicting post-induction hypotension.
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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
기간: Within the first 15 minutes after anesthesia induction
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Effect modification of frailty level (Clinical Frailty Scale score) on the association between preoperative EASIX score and post-induction hypotension, evaluated by multivariable logistic regression with interaction term.
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Within the first 15 minutes after anesthesia induction
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mustafa Aydemir, MD, Konya City Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PIXEL-EASIX-PIH-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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