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Optimizing Cerebral Autoregulation During Surgery
NA trial testing Blood pressure management according to cerebral autoregulation in Hip Fractures in 27 participants. Completed in 30 July 2025.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 27 |
| Start date | 9 January 2023 |
| Primary completion | 28 June 2024 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across United States |
Johns Hopkins University
Adults 60 to 100, any sex, with Hip Fractures or Hip Arthropathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Extent (mmHg \* hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
| Group | Value | 95% CI |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | 2.2 | ± 2.1 |
| Standard of Care Blood Pressure Management | 1.8 | ± 1.2 |
Blood loss during surgery (mL).
| Group | Value | 95% CI |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | 17.5 | ± 17.8 |
| Standard of Care Blood Pressure Management | 12.9 | ± 19.8 |
Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
| Group | Value | 95% CI |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | 0 | |
| Standard of Care Blood Pressure Management | 0 |
Clinically diagnosed new stroke after surgery as a measure of incidence.
| Group | Value | 95% CI |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | 0 | |
| Standard of Care Blood Pressure Management | 0 |
Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU.
| Group | Value | 95% CI |
|---|---|---|
| Blood Pressure Managed by Cerebral Autoregulation | 0 | |
| Standard of Care Blood Pressure Management | 1 |
Time frame: Up to 13-months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Blood Pressure Managed by … | Standard of Care Blood Pre… |
|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hematuria or UTI | Renal and urinary disorders | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Emphysema | Respiratory, thoracic and mediastinal disorders | — | — |
| Effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Stroke | Nervous system disorders | — | — |
| Bowel obstruction | Gastrointestinal disorders | — | — |
| Reaction | System | Blood Pressure Managed by … | Standard of Care Blood Pre… |
|---|---|---|---|
| Pneumothorax prolonged | Respiratory, thoracic and mediastinal disorders | — | — |
| Fall | Musculoskeletal and connective tissue disorders | — | — |
| Subcutaneous Emphysema | Musculoskeletal and connective tissue disorders | — | — |
| low back pain | Musculoskeletal and connective tissue disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Delirium | Nervous system disorders | — | — |
| Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Dementia | Nervous system disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
Most-reported serious reactions: Cancer, Hematuria or UTI, Atrial Fibrillation, Sepsis, Emphysema, Effusion, Myocardial infarction, Stroke.
Data from ClinicalTrials.gov NCT05308290 adverse events section.
The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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