Remote Ischemic Preconditioning and Postoperative Neuronal Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote ischemic preconditioning, Routine care.
- Who it may be relevant to
- Registry conditions: Postoperative Neuronal Injury. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial
Overview
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.
Interventions
- Other Remote ischemic preconditioning
In patients assigned to the RIPC group, we will perform RIPC on the day before surgery. - Other Routine care
Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.
Primary outcome measures
- Serum neurofilament light chain concentration [Time frame: Within the first 2 postoperative days]
Secondary outcome measures (3)
- Change in serum neurofilament light chain concentrations [Time frame: Baseline (before surgery) and within the first 2 postoperative days]
- Serum neuron-specific enolase concentration [Time frame: Postoperative day 1]
- Change in serum neuron-specific enolase concentrations [Time frame: Baseline (before surgery) and the first postoperative day]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT07420153 · 2025-101689-BOff