The use of erythropoietin in cardiac arrest victims: the impact on survival and neurological outcome

ISRCTN ISRCTN67856342
DOI https://doi.org/10.1186/ISRCTN67856342
Secondary identifying numbers CNMPEPO 001
Submission date
03/06/2007
Registration date
20/07/2007
Last edited
21/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Štefek Grmec
Scientific

Ulica talcev 9
Maribor
2000
Slovenia

Study information

Study designProspective, multi-centre (three emergency medical service centres) randomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymCNMPEPO
Study objectivesPre-hospital teams are often confronted with a problem of cardiac arrest patients. Every minute without CPR reduces survival by 10 to 15%. In our pre-hospital setting there is 50% success in returning the spontaneous circulation (Return Of Spontaneous Circulation, ROSC) after CPR. Only half of these patients survive to discharge from hospital.
That is why more thoughts should be pointed to intra- and post-reanimation care meaning preservation and protection of the brain and heart function. Only this provides the chance of survival to be wholesome. Immediately after ROSC there is a period of brain hyperemia. 15 to 30 minutes after ROSC brain perfusion decreases and because the autoregulation of the brain is lost, perfusion of the brain mainly depends upon mean arterial pressure. Brain oedema, focal haemorrhages and instability of circulation lead to further brain ischaemic lesions.

The aim of our research is to determine the impact of erythropoietin on survival and neurological outcome of cardiac arrest victims. On the basis of previous preclinical and clinical data about eryrhropoietin (EPO) therapy for acute stroke and acute myocardial infarction we expect that giving erythropoietin early in the course of cardiopulmonary resuscitation would decrease the ischaemic and reperfusion damage to the brain and heart.

Hypothesis: The group of patients in cardiac arrest who are treated with erythropoietin have better survival (discharge from hospital) and neurological outcome (Cerebral Performance Category [CPC]). We expect that giving erythropoietin early in the course of cardiopulmonary resuscitation would decrease the ischaemic and reperfusion damage to the brain and heart after a period of cardiac arrest and thus it would improve neurological outcome of these patients. Key questions are:
1. What is the survival rate of the patients who received EPO compared to those who didn't?
2. Does the new approach to the cardiac arrest victims improve their survival?
3. Is there any difference in the neurological outcome between the two groups?
Ethics approval(s)The National Medical Ethics Committee of Republic of Slovenia, approved on 23/01/2007 (ref: KME 37/01/07)
Health condition(s) or problem(s) studiedCardiac arrest
InterventionThe patients in the intervention group will receive a bolus of EPO (90000 IU) in first four minutes during the CPR process. Intraosseous route is an alternative. Early application of the drug is crucial to cover the period of ischaemia and reperfusion which are both connected with brain in myocardial injury and possibility of malignant heart arrhythmias. In the case of ROSC all the patinets will be cooled down by the process of induced therapeutic hypothermia receiving sterile physiological saline with the temperature of 4°C and the speed 100 ml/hour.

Both intervention and control groups (group with and without erythropoietin) will be treated according the latest guidelines for cardiopulmonary resuscitation (the International Liaison Committee on Resuscitation [ILCOR] - European Resuscitation Council).

All the data will be collected under the ILCOR recommendation in Utstein style and checked by two independent researchers. Neurological function of the patients will be assessed and categorized with Cerebral Performance Score (CPS).

The following data will also be collected:
1. Capnometry
2. Initial heart rhythm
3. Age
4. Gender
5. Withness of cardiac arrest
6. Lay bystanders CPR
7. Response time
8. Respiratory Rate (RR)
9. Echocardiography
10. Protein S 100
11. Creatinine Kinase (CK)
12. Sodium (Na)
13. Chloride (Cl)
14. Pottasium (K)
15. Calcium (Ca)
16. Magnesium (Mg)
17. Lactate
18. Brain Computed Tomography (CT)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)erythropoietin
Primary outcome measureNeurological outcome assessed by CPC, from CPC-1 (normal neorological status) to CPC-5 (brain death). This will be measured six months after cardiopulmonary resuscitation.
Secondary outcome measures1. ROSC in the field (%)
2. ROSC with admission to hospital
3. 24-hour survival
4. Survival (discharge from hospital)
Overall study start date01/06/2007
Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. 18 years or older
2. Non-traumatic, cardiac arrest in pre-hospital setting when started with cardiopulmonary reanimation irrespective of initial cardiac rhythm
Key exclusion criteria1. Traumatic cardiac arrest
2. Under 18 years of age
3. Cardiopulmonary Resuscitation (CPR) without drugs (only defibrillation)
4. Pregnancy
5. Severe hypothermia (<30°C)
Date of first enrolment01/06/2007
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Ulica talcev 9
Maribor
2000
Slovenia

Sponsor information

Centre for Health and Emergency Medicine (Zdravstveni dom adolfa drolca maribor) (Slovenia)
Hospital/treatment centre

Ulica talcev 9
Maribor
2000
Slovenia

http://www.zd-mb.si/
ROR logo https://ror.org/01j9yjt02

Funders

Funder type

Hospital/treatment centre

Centre for Health and Emergency Medicine (Zdravstveni dom adolfa drolca maribor) (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2009 Yes No
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