Postoperative Neuronal InjurySHIELDNCT07420153
Remote Ischemic Preconditioning and Postoperative Neuronal Injury
A study testing Remote ischemic preconditioning and Routine care in people with Postoperative Neuronal Injury, run by University of Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Postoperative Neuronal Injury
- What is being tested?
- Remote ischemic preconditioning and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bernd Saugel contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Alina Bergholz, a.bergholz@uke.de
About this study
Official title: 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.
- Conditions
- Postoperative Neuronal Injury
- Being tested
- Remote ischemic preconditioning, Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningOther
In patients assigned to the RIPC group, we will perform RIPC on the day before surgery.
Routine careOther
Patients assigned to the No-RIPC group will receive routine care and RIPC will not be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum neurofilament light chain concentration
Maximum serum NfL concentration
Measured: Within the first 2 postoperative days
Secondary outcomes (3)
Change in serum neurofilament light chain concentrations
Change in serum NfL concentrations from baseline to the maximum value within the first 2 postoperative days
Measured: Baseline (before surgery) and within the first 2 postoperative days
Serum neuron-specific enolase concentration
NSE serum concentration at postoperative day 1
Measured: Postoperative day 1
Change in serum neuron-specific enolase concentrations
Change in serum NfL concentrations from baseline to postoperative day 1
Measured: Baseline (before surgery) and the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start2 Mar 2026
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Neuronal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alina Bergholz, University of Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420153
- Sponsor's protocol ID
- 2025-101689-BOff
- Other IDs
- 2025
- Acronym
- SHIELD
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning and Postoperative Neuronal Injury in Non-Cardiac Surgery Patients: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07420153
- Acronym / sponsor ID
- SHIELD / 2025-101689-BOff
- Conditions
- Postoperative Neuronal Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of Hamburg-EppendorfUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Other: Remote ischemic preconditioningIn 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. |
| No-RIPC group | Active comparator | Other: Routine carePatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningIn patients assigned to the RIPC group, we will perform RIPC on the day before surgery. | Other | RIPC group |
| Routine carePatients assigned to the No-RIPC group will receive routine care and RIPC will not be performed. | Other | No-RIPC group |
Primary outcome
Serum neurofilament light chain concentration
Time frame: Within the first 2 postoperative days
Maximum serum NfL concentration
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernd Saugel contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning and Routine care in people with Postoperative Neuronal Injury, run by University of Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Bergholz (004940 7410 0, a.bergholz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum neurofilament light chain concentration (time frame: Within the first 2 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.