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Remote Ischemic Preconditioning and Postoperative Neuronal Injury | Clinical Trials | Clareo Health

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Remote Ischemic Preconditioning and Postoperative Neuronal Injury

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

NCT07420153•University of Hamburg-Eppendorf

Summary

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany

Key Dates

Start Date

March 2, 2026

Primary Completion Date

August 1, 2027

Completion Date

September 1, 2027

Last Updated

March 4, 2026

Enrollment

216

ESTIMATED participants

Conditions

Postoperative Neuronal Injury

Interventions

Remote ischemic preconditioning

OTHER

Routine care

OTHER

Contacts

Alina Bergholz

CONTACT

004940 7410 0 a.bergholz@uke.de

Bernd Saugel

CONTACT