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Clinical importance of biomarkers in the management and to predict survival of critically ill patients after resuscitation from cardiac arrest in Emergency Departament.

Neuron-specific enolase, S100B and Resistin - Clinical importance of biomarkers in the management and to predict survival of critically ill patients after resuscitation from cardiac arrest in Emergency Departament.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001540404
Enrollment
40
Registered
2016-11-08
Start date
2017-01-12
Completion date
2017-10-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cardio-respiratory arrest (CRA) remains a major health problem with great implications for the emotional and financial impact of the patient, the family and society. The management of cardiac arrest patients represents an ongoing challenge to clinicians in order to reduce mortality and restore patient functionality with minimal disability. Current research in medicine have the foreground of identifying biomarkers useful in assessing the diagnosis, risk stratification, therapy and prognosis of cardiac arrest patients admitted in the emergency department. The study aimed to determine the role of biomarkers – NSE, protein S-100B and resistin - along with clinical data to assess early prognosis (survival at 30 days of admission to study) and the opportunity to further develop the protocols management of the diagnosis and treatment of patients resuscitated after CRA depending on the level of these markers. Our primary objective is to determine the correlation between serum levels of resistin, NSE and protein S100B (dosed at predetermined time intervals) and the severity of organ dysfunction, to predict survival prognosis and neurological outcome in patients with CRA. Our secondary objectives are: - the correlation between serum levels of resistin and duration of resuscitation until they get ROSC (return of spontaneous circulation) assessed through review of medical records. - the correlation between the serum levels of resistin and the pathology that led to the occurrence of the CRA. - determining cutoff values that predict poor outcomes and determin survival correlated with the serum levels of biomarkers studied. Observational study, prospective, single-center, will include CRA resuscitated patients admitted to ED with enrolled inclusion and exclusion criteria very well established. All patients will receive customary blood sampling and biological samples that characterize the specific pathology/comorbidities in each case, the radiology and imagistic medical case management needed. Determinations will be done for each biomarker in preestablish time intervals set in the study protocol and following manufacturers indications of sampling and storage. It will mark the benchmarks of the results obtained in the study. Monitoring data will be done after severity scores SOFA, CPC, serum levels of sampling biomarkers studied and after patient survival duration. Statistical analysis will be performed according to rigors established from information resulting from demographic data, levels of serum markers and parameters evaluated in the study. With this study we hope to bring more informations to the current research, identifying the role of biomarkers and correlating the levels with the survival, identifying the biomarkers with high specificity and sensitivity to predict survival in critically ill patients after resuscitation from cardiac arrest in ED and setting up the future protocols for management in resuscitated patients.

Interventions

In this study we try to identify the role of biomarkers: Neuron specific enolase (NSE), S-100B protein, resistin in the management of critically ill patients and to predict survival after resuscitation from cardiac arrest within 30 days. The biomarkers seric level will be determinate at time 0 (T0- the moment of the admission in ED- Emergency Department) , and T6, T12, T24, T48 and T72 hours from the admission, using the ELISA technique. For each biomarker we will strictly follow the producer in

In this study we try to identify the role of biomarkers: Neuron specific enolase (NSE), S-100B protein, resistin in the management of critically ill patients and to predict survival after resuscitation from cardiac arrest within 30 days. The biomarkers seric level will be determinate at time 0 (T0- the moment of the admission in ED- Emergency Department) , and T6, T12, T24, T48 and T72 hours from the admission, using the ELISA technique. For each biomarker we will strictly follow the producer instruction for sampling blood, determination and conservation.  The results of these biomarkers determined by the patients admitted in the study (who meet the inclusion criteria) will be compared with values obtained from 40 healthy volunteers interpreted as normal reference values. Correlation between the level of biomarkers with Sequential Organ Failure Assessment (SOFA) and Cerebral Performance Category (CPC) to establish the outcome of survival after resuscitation from cardiac arrest patients. The SOFA score will be calculate at the moment of admission in the study and at 24, 48, 72 hours. The CPC score will calculate at the moment of admission in the study and at 24, 48, 72 hours and to hospital discharge, at 30 days or at the moment of recording the death (if death occurred until the end of the 30 days of monitoring). And we will also note date when the death occurred.

Sponsors

Iuliu Hatieganu UMF Cluj-Napoca, Romania
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

- age over 18 and under 85 years - cardiac arrest with ROSC (return of spontaneous circulation) - GCS (coma Glasgow score) >/=3

Exclusion criteria

- age under 18 and over 85 years - pregnant women - sever brain trauma, politrauma, major burns - cardiac arrest secondary to acute bleeding - cardiac arrest without ROSC in the first 6 hours after admission - cardiac arrest secondary to hypothermia - terminal neoplasia - patients in detention - patients with informed consent not obtained

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026