Remote ischemic preconditioning: In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Routine care: Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.
Study 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
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* 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 criteria:
* 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
Primary outcome measure(s)
Serum neurofilament light chain concentration — Within the first 2 postoperative days Maximum serum NfL concentration
Trial sites (1)
Facility
City
Region
Status
University Medical Center Hamburg-Eppendorf
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More University of Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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