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NCT Number: NCT07642765

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

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.

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Key information

Conditions

Hypotension on Induction Anesthesia, General Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EASIX Score Assessment

Other

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.

Primary outcomes

  1. Incidence of Post-Induction Hypotension

    Time frame: Within the first 15 minutes after anesthesia induction

    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.

Secondary outcomes

  1. Diagnostic Performance of EASIX Score for Post-Induction Hypotension

    Time frame: Preoperative assessment within 24 hours before surgery

    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.

  2. Interaction Between Frailty Severity and EASIX on Post-Induction Hypotension

    Time frame: Within the first 15 minutes after anesthesia induction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa Aydemir, MD

CONTACT

[email protected]

+903323105000

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

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

Acronym: PIXEL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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