New Tools and Predictive Markers in the Prognosis of Hypoxic-ischemic Encephalopathy Following Cardiac Arrest

NCT07464938 | Recruiting

• 1 other identifier: 2025/19DEC/536
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac arrest (CA) remains a major cause of mortality and long-term neurological disability worldwide. Despite advances in resuscitation, many survivors suffer from post-cardiac syndrome encompassing PCAS brain injury (PCABI), due to primary (ischemic) and secondary (reperfusion) injury, myocardial dysfunction, systemic response, and persistent underlying causes. PCABI plays a critical role in this complex condition, which is characterized by ischemia, inflammation, and microvascular dysfunction.Current methods to predict neurological outcomes are limited, leading to challenges in clinical decision-making and the risk of premature withdrawal of life-sustaining therapies. This study aims to improve prognostication in CA patients by integrating advanced serum biomarker profiling with cerebral ultrasound (CU) techniques. The investigators hypothesize that combining these tools with clinical data will enhance the accuracy of neurological outcome predictions and deepen understanding of PCABI pathophysiology. The investigators will prospectively enroll 50 CA patients admitted to the intensive care unit at Cliniques Universitaires Saint-Luc. Serum proteomics will be performed using the Reveal panel from Olink®, which analyzes over 1,000 proteins involved in inflammation and thrombosis implicated in PCABI. Concurrently, cerebral ultrasound will assess optic nerve sheath diameter (ONSD) and cerebral blood flow velocities (CBFV) at multiple time points post-resuscitation (at admission, on day 1-2 and on day 3-5). These non-invasive bedside measurements may serve as early indicators of elevated intracranial pressure and cerebral hemodynamic abnormalities.The primary endpoint is poor neurological outcome at one month, defined by the Cerebral Performance Category (CPC) scale. Statistical analyses will evaluate the prognostic value of biomarkers and ultrasound parameters individually and in combination with established clinical predictors.This multimodal approach promises to refine prognostic accuracy, improve clinical decision-making, and identify novel therapeutic targets. Ultimately, our findings may lead to improved patient outcomes and guide future multicenter studies for validation and clinical implementation.

Conditions

Cardiac Arrest (CA)

Keywords

cardiac arrest; proteomic; Cerebral ultrasounds; neuroprognostication

Outcome Measures

Primary Outcomes (1)

• Neurological outcome

  The Cerebral Performance Category (CPC) scale assesses neurological outcome after cardiac arrest at 3 months. CPC 1: Good cerebral performance; normal life or mild neurological deficit. CPC 2: Moderate cerebral disability; independent in activities of daily living. CPC 3: Severe cerebral disability; dependent for daily support. CPC 4: Coma or persistent vegetative state. CPC 5: Brain death or death.

  Throughout the entire study, approximately during 2 years

Secondary Outcomes (3)

• Proteomics-based serum alteration (thrombosis and inflammation panel)

  Throughout the entire study, approximately during 2 years

• Cerebral ultrasound parameters and outcome prediction

  Throughout the entire study, approximately during 2 years

• ONSD and neurological outcome

  Throughout the entire study, approximately during 2 years

Study Arms (1)

Ou-of-Hospital Cardiac Arrest (OHCA) patients

EXPERIMENTAL

Diagnostic Test: This study aims to improve prognostication in OHCA patients by integrating advanced serum biomarker profiling with cerebral ultrasound techniques (flow velocities, optic nerve sheath diameter)

Interventions

This study aims to improve prognostication in OHCA patients by integrating advanced serum biomarker profiling with cerebral ultrasound techniques (flow velocities, optic nerve sheath diameter) DIAGNOSTIC_TEST

Cerebral ultrasound and blood serum samples will be collected at three time points. EEG, SSEP, and clinical examination will be performed as standard of care.

Ou-of-Hospital Cardiac Arrest (OHCA) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-year-old with OHCA admitted to our hospital receiving routine care.

You may not qualify if:

• Patients transferred from other hospitals for OHCA management
• Patients with pre-existent neurological disease.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Pasquale Scoppettuolo, MD

CONTACT

+3227618176; pasquale.scoppettuolo@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 11, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)