eCRF questions

DISCO-TRIAL

eCRF Questions:



If the patient dies, what do we do with informed consent? If the patient dies before 24h or after?

We always need informed consent, no matter how long the patient has been included.


However:


If the patient dies without regaining consciousness, and doesn't have a relative ore next of kin to sign an I.C?

We always need informed consent. However the steering committee have decided that this kind of patient is included in the study, despite the lack of informed consent.  That is, we collect the data we need for the study.

A thorough search for relatives needs to be done before the decision is made to include the patient. Always contact P.I. at Uppsala University Hospital when these situations occurs.


Can we start an eCRF for someone without an informed consent?

No, you need an informed consent from the patient or next of kin before writing in the eCRF. (You can document in the pCRF before, if you prefer)



Highest temp and lactate the first day.

Remember that the values from the emergency room all the way to the next day, should be considered when evaluating the first day.


Bloodsamples

Remember that first Troponin or NtproBNP could be taken in the ER. You don't have to "start over" when the patient arrives in the ICU.

NtproBNP does not have to be taken exactly 72h after the first sample, but as close as possible. The most common thing is to take NtproBNP in the morning with all the other samlpes.


GCS

If the patient is sedated the entire day, you cannot evaluate GCS. But if there is a wake-up test, the evaluated GCS should be documented in the eCRF.



Arterial blood gas time is not exactly 4h in between.

That is all right, just as long as it is as close as possible to 4h between the samples.



Time intubated?

The total time intubated is what we want to know. If the patient is extubated and then intubated again before finally extubated-you add the total time intubated.



Concomittant medication changes

Conmed has gone through some changes since the pilot phase. Now we just want you to document if they have received any of the specified medicines during the first 96h.

The 96 hours documentation of conmeds will most likely occur over day 1-5 due to the time of patient inclusion Therefore, you have the option to register 1- 5 days in the eCRF.



CPC and mRS at discharge, who is responsible for calculating this?

It does not have to be a doctor. You can talk to the staff at ICU or the ward where the patient arrived at and then use the tool to assess CPC and mRS.


AE and Angio in pCRF

In the pCRF the AE and angio part must be signed by a doctor if used as source data

AE needs to be documented if you think an incident occured that could have to do with the study in some way.


ECHOCARDIOGRAM values

If for example EF is 55-60, please document the lowest value.