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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001540404
• Date of registration: 08/11/2016
• Prospective Registration: Yes
• Primary sponsor: Iuliu Hatieganu UMF Cluj-Napoca, Romania
• 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.
• Date of first enrolment: 12/01/2017
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001540404.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Romania

Contacts

• Name: Dr Raluca - Mihaela Tat

• Name: Dr Raluca - Mihaela Tat

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Other cardiovascular diseases

cardiac arrest;
cardiac arrest

Intervention(s)

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.

Primary Outcome(s)

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

Secondary Outcome(s)

The correlation between serum levels of resistin to determin cutoff values that predict survival after CRA assessed by values obtained with statistical methods [Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

The correlation between serum levels of resistin and pathology that led to the occurrence of the CRA assessed by review of medical records.[Timepoint : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

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 : - T0 - the admission in the Emergency Department
- T6, T12, T24, T48 and T72 hours post presentation to ED]

Secondary ID(s)

none

Source(s) of Monetary Support

Iuliu Hatieganu UMF Cluj-Napoca, Romania

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Scientific Research - UMF Cluj-Napoca, Romania