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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC group | Experimental | In patients assigned to the RIPC group, we will perform RIPC on the day before surgery. If surgery is postponed, RIPC will be repeated on the day before the rescheduled surgery. RIPC will be performed with 3 cycles of upper-arm ischemia for 5 minutes followed by reperfusion for 5 minutes, using a blood pressure cuff inflated to 200 mmHg or to 50 mmHg above the systolic arterial pressure, whichever is higher. |
|
| No-RIPC group | Active Comparator | Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed. No sham procedure will be applied, given the objective nature of the primary outcome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Other | In patients assigned to the RIPC group, we will perform RIPC on the day before surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum neurofilament light chain concentration | Maximum serum NfL concentration | Within the first 2 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum neurofilament light chain concentrations | Change in serum NfL concentrations from baseline to the maximum value within the first 2 postoperative days | Baseline (before surgery) and within the first 2 postoperative days |
| Serum neuron-specific enolase concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | Incidence of postoperative delirium within the first 3 postoperative days | Within the first 3 postoperative days |
| Quality of recovery | Quality of recovery on postoperative day 3 |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alina Bergholz | Contact | 004940 7410 0 | a.bergholz@uke.de | |
| Bernd Saugel | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
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Clinicians involved in perioperative care and laboratory staff will be blinded to group allocation.
| Routine care | Other | Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed. |
|
NSE serum concentration at postoperative day 1 |
| Postoperative day 1 |
| Change in serum neuron-specific enolase concentrations | Change in serum NfL concentrations from baseline to postoperative day 1 | Baseline (before surgery) and the first postoperative day |
| Postoperative day 3 |
| All-cause mortality | All-cause mortality within the first 30 postoperative days | Within the first 30 postoperative days |