NCT07420153

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

February 11, 2026

Last Update Submit

March 2, 2026

Conditions

Postoperative Neuronal Injury

Outcome Measures

Primary Outcomes (1)

  • Serum neurofilament light chain concentration

    Maximum serum NfL concentration

    Within the first 2 postoperative days

Secondary Outcomes (3)

  • Change in serum neurofilament light chain concentrations

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

  • Serum neuron-specific enolase concentration

    Postoperative day 1

  • Change in serum neuron-specific enolase concentrations

    Baseline (before surgery) and the first postoperative day

Other Outcomes (3)

  • Postoperative delirium

    Within the first 3 postoperative days

  • Quality of recovery

    Postoperative day 3

  • All-cause mortality

    Within the first 30 postoperative days

Study Arms (2)

RIPC group

EXPERIMENTAL

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

No-RIPC group

ACTIVE COMPARATOR

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

Interventions

Remote ischemic preconditioningOTHER

In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.

RIPC group
Routine careOTHER

Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.

No-RIPC group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

Central Study Contacts

Alina Bergholz

CONTACT

004940 7410 0a.bergholz@uke.de

Bernd Saugel

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Clinicians involved in perioperative care and laboratory staff will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 19, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

DE(1)