Remote Ischemic Preconditioning and Postoperative Neuronal Injury (SHIELD)

Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Neuronal Injury
• Intervention / Treatment: Other: Remote ischemic preconditioning; Other: Routine care

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernd Saugel
• Study Contact Backup: Name: Alina Bergholz; Phone Number: 004940 7410 0; Email: a.bergholz@uke.de

Study Locations

• Germany
  • Hamburg
    • Hamburg, Hamburg, Germany, 20246
      • Recruiting
      • University Medical Center Hamburg-Eppendorf
      • Contact: Alina Bergholz; Email: a.bergholz@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC group; 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.	Other: Remote ischemic preconditioning; In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Active Comparator: No-RIPC group; 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.	Other: Routine care; Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum neurofilament light chain concentration	Maximum serum NfL concentration	Within the first 2 postoperative days

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	Postoperative day 3
All-cause mortality	All-cause mortality within the first 30 postoperative days	Within the first 30 postoperative days

Collaborators and Investigators

• Sponsor: University of Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-101689-BOff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No