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

NCT07642765 | Not Yet Recruiting

• 1 other identifier: PIXEL-EASIX-PIH-2026
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension on Induction; Frailty; Anesthesia, General

Keywords

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

Outcome Measures

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.

  Within the first 15 minutes after anesthesia induction

Secondary Outcomes (2)

• Diagnostic Performance of EASIX Score for Post-Induction Hypotension

  Preoperative assessment within 24 hours before surgery

• Interaction Between Frailty Severity and EASIX on Post-Induction Hypotension

  Within the first 15 minutes after anesthesia induction

Study Arms (1)

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.

Other: EASIX Score Assessment

Interventions

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.

Frail Patients Undergoing Non-Cardiac Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Cardiac surgery
• Emergency surgery
• Preoperative vasopressor infusion
• Severe hematological disease
• Missing laboratory data required for EASIX calculation

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42200, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 28974066 BACKGROUND

• 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.

  PMID: 30236233 BACKGROUND

• 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.

  PMID: 30144029 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

• 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.

  PMID: 28733186 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mustafa Aydemir, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Aydemir, MD

CONTACT

+903323105000; drmustafaaydemir02@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)