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Trial registered on ANZCTR


Registration number
ACTRN12616001540404
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
8/11/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical importance of biomarkers in the management and to predict survival of critically ill patients after resuscitation from cardiac arrest in Emergency Departament.
Scientific title
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.
Secondary ID [1] 290307 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac arrest 300562 0
Condition category
Condition code
Cardiovascular 300419 300419 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
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.
Intervention code [1] 296118 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299861 0
The correlation between serum levels of resistin, with severity of organ dysfunction assessed by SOFA to predict survival prognosis (survival to 30 days) in patients with cardiorespiratory arrest (CRA).
Timepoint [1] 299861 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Primary outcome [2] 299985 0
The correlation between serum levels of enolase specific neuron with severity of neuronal dysfunction assessed by CPC to predict neurological outcome (at 30 days) in patients with cardiorespiratory arrest (CRA).
Timepoint [2] 299985 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Primary outcome [3] 299986 0
The correlation between serum levels of protein S100B with severity of neuronal dysfunction assessed by CPC to predict neurological outcome (at 30 days) in patients with cardiorespiratory arrest (CRA).
Timepoint [3] 299986 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Secondary outcome [1] 328330 0
The correlation between serum levels of resistin to determin cutoff values that predict survival after CRA assessed by values obtained with statistical methods
Timepoint [1] 328330 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Secondary outcome [2] 328583 0
The correlation between serum levels of resistin and pathology that led to the occurrence of the CRA assessed by review of medical records.
Timepoint [2] 328583 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Secondary outcome [3] 328584 0
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.
Timepoint [3] 328584 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Secondary outcome [4] 328762 0
The correlation between serum levels of enolase specific neuron to determin cutoff values that predict poor neurological outcomes assessed by values obtained with statistical methods.
Timepoint [4] 328762 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED
Secondary outcome [5] 328763 0
The correlation between serum levels of protein S100B to determin cutoff values that predict poor neurological outcomes assessed by values obtained with statistical methods.
Timepoint [5] 328763 0
Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED

Eligibility
Key inclusion criteria
- age over 18 and under 85 years
- cardiac arrest with ROSC (return of spontaneous circulation)
- GCS (coma Glasgow score) >/=3
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis of data will be done with parametric and nonparametric tests depending on the parameter analyzed data and the distribution on the study group. If needed, be applied a specific correction type to serial determinations for multiple values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
12/01/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
8/10/2017
Date of last data collection
Anticipated
4/12/2017
Actual
8/11/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8305 0
Romania
State/province [1] 8305 0
Cluj county, Cluj-Napoca city

Funding & Sponsors
Funding source category [1] 294689 0
University
Name [1] 294689 0
Iuliu Hatieganu UMF Cluj-Napoca, Romania
Country [1] 294689 0
Romania
Primary sponsor type
University
Name
Iuliu Hatieganu UMF Cluj-Napoca, Romania
Address
Victor Babes street, no.8, Cluj-Napoca City, Cluj county, postal code 400012, Romania
Country
Romania
Secondary sponsor category [1] 293533 0
None
Name [1] 293533 0
Address [1] 293533 0
Country [1] 293533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296114 0
Ethics Committee of Scientific Research - UMF Cluj-Napoca, Romania
Ethics committee address [1] 296114 0
Louis Pasteur street, no. 4-6, Cluj-Napoca city, Cluj county, postal code 400349, Romania
Ethics committee country [1] 296114 0
Romania
Date submitted for ethics approval [1] 296114 0
17/02/2016
Approval date [1] 296114 0
14/03/2016
Ethics approval number [1] 296114 0
59

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69598 0
Dr Raluca - Mihaela Tat
Address 69598 0
Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
Country 69598 0
Romania
Phone 69598 0
+ 40026431876
Fax 69598 0
Email 69598 0
[email protected]
Contact person for public queries
Name 69599 0
Raluca - Mihaela Tat
Address 69599 0
Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
Country 69599 0
Romania
Phone 69599 0
+ 40026431876
Fax 69599 0
Email 69599 0
[email protected]
Contact person for scientific queries
Name 69600 0
Raluca - Mihaela Tat
Address 69600 0
Emergency County Hospital Cluj-Napoca, Clinicilor street, no. 3-5, Cluj-Napoca City, Cluj County, Romania, 400006
Country 69600 0
Romania
Phone 69600 0
+ 40026431876
Fax 69600 0
Email 69600 0
[email protected]

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