University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT07420153
Remote Ischemic Preconditioning and Postoperative Neuronal Injury
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Remote Ischemic Preconditioning
OtherIn patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Routine care
OtherPatients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.
Primary outcomes
-
Serum neurofilament light chain concentration
Time frame: Within the first 2 postoperative days
Maximum serum NfL concentration
Secondary outcomes
-
Change in serum neurofilament light chain concentrations
Time frame: 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
Time frame: Postoperative day 1
NSE serum concentration at postoperative day 1
-
Change in serum neuron-specific enolase concentrations
Time frame: Baseline (before surgery) and the first postoperative day
Change in serum NfL concentrations from baseline to postoperative day 1
Other outcomes
-
Postoperative delirium
Time frame: Within the first 3 postoperative days
Incidence of postoperative delirium within the first 3 postoperative days
-
Quality of recovery
Time frame: Postoperative day 3
Quality of recovery on postoperative day 3
-
All-cause mortality
Time frame: Within the first 30 postoperative days
All-cause mortality within the first 30 postoperative days
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Hamburg-Eppendorf
Other
Registry information
Official study title
Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial
Acronym: SHIELD
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 19, 2026
- Registry last updated
- Mar 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.