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RecruitingNot ApplicableNCT07420153

Remote Ischemic Preconditioning and Postoperative Neuronal Injury

Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial

Sponsor

University of Hamburg-Eppendorf

Enrollment

216 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Postoperative Neuronal Injury

Summary

The SHIELD trial is a single-center, randomized, controlled, parallel-group, single-blinded clinical trial investigating whether performing RIPC one day before surgery-compared to not performing RIPC-reduces postoperative neuronal injury, as reflected by the maximum serum NfL concentration within the first 2 postoperative days, in non-cardiac surgery patients at risk for postoperative delirium.

Eligibility

Min Age: 50 Years

Inclusion Criteria2

  • patients (≥50 years) scheduled for elective non-cardiac surgery with general anesthesia
  • patients at risk for postoperative delirium, defined as the presence of ≥2 of the following established risk factors: age ≥65 years, American Society of Anesthesiologists physical status classification of ≥III, Charlson Comorbidity, planned surgical duration >180 minutes, polypharmacy (regular intake of more than five medications), symptoms of depression (Patient Health Questionnaire-9 ≥10 points)

Exclusion Criteria8

  • patients in whom RIPC cannot be safely applied due to relevant peripheral arterial disease (defined as Fontaine stage ≥II), lymphedema, recent upper-arm surgery, trauma, or skin lesions at the arm
  • patients with acute coronary syndrome (within the past month)
  • patients with surgery in the previous month
  • patients with intracranial surgery
  • patients with pre-existing delirium
  • patients with severe cognitive impairment preventing reliable delirium assessment
  • patients with current treatment with sulfonamides due to potential interference with ischemic preconditioning mechanisms
  • patients with previous participation in the SHIELD trial

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Interventions

OTHERRemote ischemic preconditioning

In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.

OTHERRoutine care

Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.

Locations(1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, Germany

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NCT07420153