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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients transferred from other hospitals for OHCA management

Patients with pre-existent neurological disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Ou-of-Hospital Cardiac Arrest (OHCA) patientsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Throughout the entire study, approximately during 2 years

Secondary outcomes

1

Proteomics-based serum alteration (thrombosis and inflammation panel)

Proteomics-based analysis of serum alterations focusing on thrombosis and inflammation pathways

Time frame
Throughout the entire study, approximately during 2 years
2

Cerebral ultrasound parameters and outcome prediction

Cut-off for hemodynamic parameters after CA (Peak Sysolic Velocity and End Diastolic Veclocity, cm/s) and the Resistance Index (RI) and Pulsatility Index (PI) are dimensionless Doppler parameters, as they are calculated as ratios of flow velocities, for unfavourable and favorable outcome/mortality

Time frame
Throughout the entire study, approximately during 2 years
3

ONSD and neurological outcome

Optic nerve sheath ultrasound (ONSD) cut-off (mm) for unfavourable and favorable outcome/mortality

Time frame
Throughout the entire study, approximately during 2 years

Other outcomes

Sponsors and contacts

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