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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Remote ischemic preconditioning
Other intervention
In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Routine care
Other intervention
Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.

Treatment groups

216 Participants

are divided into 2 treatment groups

Group A: RIPC groupExperimental treatment 1 intervention

Group B: No-RIPC groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Serum neurofilament light chain concentration

Maximum serum NfL concentration

Time frame

Within the first 2 postoperative days

Secondary outcomes

Change in serum neurofilament light chain concentrations

Change in serum NfL concentrations from baseline to the maximum value within the first 2 postoperative days

Time frame

Baseline (before surgery) and within the first 2 postoperative days

Serum neuron-specific enolase concentration

NSE serum concentration at postoperative day 1

Time frame

Postoperative day 1

Change in serum neuron-specific enolase concentrations

Change in serum NfL concentrations from baseline to postoperative day 1

Time frame

Baseline (before surgery) and the first postoperative day

Other outcomes

Postoperative delirium

Incidence of postoperative delirium within the first 3 postoperative days

Time frame

Within the first 3 postoperative days

Quality of recovery

Quality of recovery on postoperative day 3

Time frame

Postoperative day 3

All-cause mortality

All-cause mortality within the first 30 postoperative days

Time frame

Within the first 30 postoperative days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hamburg-Eppendorf

Lead sponsor

Source ClinicalTrials.gov

Apply now