Using brief arm blood-flow interruptions before surgery to reduce postoperative brain injury
Official title: Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial
Run by University of Hamburg-Eppendorf · NCT07420153 · Data updated 2026-11-12
This trial will try whether doing short, repeated arm blood-flow interruptions one day before elective non-cardiac surgery can lower early blood markers of brain injury in adults 50 and older who are at risk for postoperative delirium.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 216 (estimated) |
| Sponsor | University of Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | August 2027 |
| Study ends | September 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07420153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 50 or older scheduled for elective non-cardiac surgery under general anesthesia who meet at least two predefined risk factors for postoperative delirium are ideal candidates.
✕Probably not a fit
Patients who cannot safely receive RIPC—such as those with significant peripheral arterial disease, arm lymphedema or wounds, recent upper-arm surgery, acute coronary syndrome, intracranial surgery, pre-existing delirium, or severe cognitive impairment—are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, controlled, parallel-group, single-blinded trial compares remote ischemic preconditioning (RIPC) applied one day before surgery to routine care in adults undergoing elective non-cardiac surgery. RIPC is delivered by brief, repeated arm cuff inflations to trigger systemic protective responses. The primary outcome is the maximum serum neurofilament light chain (NfL) concentration measured within the first two postoperative days as a marker of neuronal injury. Eligible participants are aged 50 or older with at least two established risk factors for postoperative delirium, and key exclusions include conditions that prevent safe cuff use, recent surgery, acute coronary syndrome, intracranial surgery, pre-existing delirium, or severe cognitive impairment.
Why it matters
Potential benefit: If successful, the approach could reduce early postoperative neuronal injury and may lower rates of delirium and subsequent cognitive decline after non-cardiac surgery.
How similar studies have gone: Remote ischemic preconditioning has shown organ-protective signals in some cardiac and vascular studies but results have been mixed and its use to prevent postoperative neuronal injury is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
Study contacts
- Study coordinator: Alina Bergholz
- Email: a.bergholz@uke.de
- Phone: 004940 7410 0
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.