Condition category
Circulatory System
Date applied
03/06/2007
Date assigned
20/07/2007
Last edited
21/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Štefek Grmec

ORCID ID

Contact details

Ulica talcev 9
Maribor
2000
Slovenia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CNMPEPO 001

Study information

Scientific title

Acronym

CNMPEPO

Study hypothesis

Pre-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

The National Medical Ethics Committee of Republic of Slovenia, approved on 23/01/2007 (ref: KME 37/01/07)

Study design

Prospective, multi-centre (three emergency medical service centres) randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cardiac arrest

Intervention

The 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 type

Drug

Phase

Not Specified

Drug names

erythropoietin

Primary outcome measures

Neurological 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 measures

1. ROSC in the field (%)
2. ROSC with admission to hospital
3. 24-hour survival
4. Survival (discharge from hospital)

Overall trial start date

01/06/2007

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older
2. Non-traumatic, cardiac arrest in pre-hospital setting when started with cardiopulmonary reanimation irrespective of initial cardiac rhythm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Traumatic cardiac arrest
2. Under 18 years of age
3. Cardiopulmonary Resuscitation (CPR) without drugs (only defibrillation)
4. Pregnancy
5. Severe hypothermia (<30°C)

Recruitment start date

01/06/2007

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Slovenia

Trial participating centre

Ulica talcev 9
Maribor
2000
Slovenia

Sponsor information

Organisation

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

Sponsor details

Ulica talcev 9
Maribor
2000
Slovenia

Sponsor type

Hospital/treatment centre

Website

http://www.zd-mb.si/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19371997

Publication citations

  1. Results

    Grmec S, Strnad M, Kupnik D, Sinkovic A, Gazmuri RJ, Erythropoietin facilitates the return of spontaneous circulation and survival in victims of out-of-hospital cardiac arrest., Resuscitation, 2009, 80, 6, 631-637, doi: 10.1016/j.resuscitation.2009.03.010.

Additional files

Editorial Notes