Remote Ischemic Preconditioning and Postoperative Neuronal Injury
ConditionPostoperative Neuronal Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Hamburg-Eppendorf
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Remote ischemic preconditioning
- Routine care
Treatment groups
216 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov