EASIX Score and Post-Induction Hypotension in Frail Patients Undergoing Non-Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKonya City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cardiac surgery
Emergency surgery
Preoperative vasopressor infusion
Severe hematological disease
Trial population
Adult frail patients (CFS score ≥4) scheduled for elective non-cardiac surgery under general anesthesia at Konya City Hospital Department of Anesthesiology and Reanimation. Patients are consecutively enrolled during the preoperative assessment period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EASIX Score Assessment
Other interventionPreoperative 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.
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Frail Patients Undergoing Non-Cardiac Surgery1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Post-Induction Hypotension
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.
Time frame
Within the first 15 minutes after anesthesia inductionSecondary outcomes
1
Diagnostic Performance of EASIX Score for Post-Induction Hypotension
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.
Time frame
Preoperative assessment within 24 hours before surgery2
Interaction Between Frailty Severity and EASIX on Post-Induction Hypotension
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.
Time frame
Within the first 15 minutes after anesthesia inductionSponsors and contacts
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Source ClinicalTrials.gov