Postoperative Neuronal Injury
Conditions
Brief 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.
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.
Sponsors
University of Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Clinicians involved in perioperative care and laboratory staff will be blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum neurofilament light chain concentration | Within the first 2 postoperative days | Maximum serum NfL concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum neurofilament light chain concentrations | Baseline (before surgery) and within the first 2 postoperative days | Change in serum NfL concentrations from baseline to the maximum value within the first 2 postoperative days |
| Serum neuron-specific enolase concentration | Postoperative day 1 | NSE serum concentration at postoperative day 1 |
| Change in serum neuron-specific enolase concentrations | Baseline (before surgery) and the first postoperative day | Change in serum NfL concentrations from baseline to postoperative day 1 |
Countries
Germany
Contacts
CONTACTAlina Bergholz
CONTACTBernd Saugel
Outcome results
None listed