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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07642765
Acronym
PIXEL
Enrollment
160
Registered
2026-06-11
Start date
2026-07-01
Completion date
2027-03-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General, Frailty, Hypotension on Induction

Keywords

Post-induction hypotension, EASIX, Endothelial Activation and Stress Index, Frailty, Perioperative hemodynamics, Non-cardiac surgery, Clinical Frailty Scale

Brief summary

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.

Detailed description

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.

Interventions

OTHEREASIX 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.

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Post-Induction HypotensionWithin the first 15 minutes after anesthesia inductionOccurrence 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

MeasureTime frameDescription
Diagnostic Performance of EASIX Score for Post-Induction HypotensionPreoperative assessment within 24 hours before surgeryArea 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.
Interaction Between Frailty Severity and EASIX on Post-Induction HypotensionWithin the first 15 minutes after anesthesia inductionEffect 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTMustafa Aydemir, MD
drmustafaaydemir02@gmail.com+903323105000
PRINCIPAL_INVESTIGATORMustafa Aydemir, MD

Konya City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026