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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGSerum neurofilament light chain concentration
Maximum serum NfL concentration
Time frame: Within the first 2 postoperative days
Change in serum neurofilament light chain concentrations
Change in serum NfL concentrations from baseline to the maximum value within the first 2 postoperative days
Time frame: Baseline (before surgery) and within the first 2 postoperative days
Serum neuron-specific enolase concentration
NSE serum concentration at postoperative day 1
Time frame: Postoperative day 1
Change in serum neuron-specific enolase concentrations
Change in serum NfL concentrations from baseline to postoperative day 1
Time frame: Baseline (before surgery) and the first postoperative day
Bernd Saugel
CONTACT
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