Frequently asked questions
Hear you can find answers to frequently asked questions regarding everything from randomization to follow-up.
OHCA: Arrest at the ER prior to final report from paramedics, non-admitted patients/relatives/care-givers whom have a cardiac arrest at the hospital or at a doctor’s appointment, patients with repeated cardiac arrests and non-sustained ROSC (<20 min) from the first OHCA at the arrival to the ER (continued events).
IHCA: Admitted patients to the hospital who have a cardiac arrest while at the hospital.
If the exact time of the cardiac arrest is unknown then use the time of call to the dispatch center. This time is recorded, it is accurate and included in the EMS forms.
Based on the intention to treat principle, data should be collected for this patient. However, the treatment goals for MAP, sedation and temperature will be up to the treating clinician. In these cases it may be an option to slightly delay the randomization until the performance of the CT brain, if there is a clear suspicion of an intracranial hemorrhage.
No the patient is not eligible and should be screened out using the criteria “Unconscious - NO”. This is because the reduced level of consciousness occurred due to a different event than the original OHCA
For unconscious patient who develop core temperature > 37.8°C within 72 h of being randomized to standard temperature management without device and for other clinical indications (anuric, acidic, hyperkalaemic etc) requires continuous renal replacement therapy (CRRT), the temperature goal should be as for other non-cardiac arrest ICU-patients (commonly CRRT with extracorporeal temperature management aimed at normothermia). If there is a refractory fever despite CRRT the temperature goal is to the discretion of the physician.
Yes, but this method of cooling should not be used routinely in place of a device. Instead, ice packs should only be used if the body temperature is sufficiently high that it would be of clinical concern outside the context of post cardiac arrest care.
Whenever possible the sedation should be kept minimal, but if clinically indicated, sedation can be increased temporarily.
No, this is perfectly acceptable and belongs to the nature of the condition.
No, sedation is to be kept constantly deep until the end of the 36-hour period.
No, pain should be treated as per routine practice and the patient can receive opioids if pain is adequately assessed and detected. Opiate infusions are OK if low doses are used and they are titrated to correspond to patient´s needs.
The sedative medication is according to clinical routine in each unit.
If the patient has seizures and other forms of antiepileptic treatments are ineffective drugs such as propofol and benzos can be used as per the treating clinician. This will be recorded in the eCRF.
This patient should not be withdrawn from the study. We suggest changing to another sedative.
First check the volume status and cardiac function. When optimized, you may try another sedative medication. If the problem remains and the noradrenaline dose is at a very high level (approaching 1 microgram/kg/min) deemed unsafe by the treating clinician, the MAP target can be reduced at increments of 5mmHg.
The MAP intervention stops when the patient is extubated or at 72 hours whichever occurs first. If the patient is extubated but then need to be reintubated before 72 hours then the allocated MAP target should be used. When the intervention stops the MAP target will be up to the treating clinician.
If possible the MAP target should be reassessed every 4-6 hours and if the situarion allows (decreasing need of a vasopressor) then the allocated MAP target should be reintated.
We do not know this for sure and it may vary between patients. In the COMACARE and NEUROPROTECT trial there were patients who received up to 1 microgram/kg/min in order to achieve the higher MAP. There was no clear indication that these patients had more severe side-effect or a worse outcome. Nonetheless if the noradrenaline dose is high the patients should be assessed on a case by case basis.
The ERC/ESICM Guidelines (https://pubmed.ncbi.nlm.nih.gov/33773827/) recommend targeting a MAP of higher than 65 mmHg. The American Heart Association and the Neurocritical Care Society target a MAP of higher than 80 mmHg (https://pubmed.ncbi.nlm.nih.gov/38040992/) unless the patient has invasive brain oxygen monitoring. Therefore there are currently no clear scientific consensus on how to manage these patients.
Protocol violations are reported through the eCRF.