UK Critical Care Genomics (UKCCG) group

Question

Answer

What’s the difference between Unavailable and Unknown? E.g. we don’t measure D-dimer ever, so which phrase should we use.

It doesn’t really matter which of the 2 phrases you use – just use the one you think most appropriate.

Are we right to assume that we are following CMP data collection definitions? If so then the following apply;

if there is only one value it should be recorded as the ‘lowest’

If there is only one value – we should enter the same result to both the lowest and highest boxes

WBC & Platelet units X10⁹/L is equivalent to X10³ mm³

Yes

Haematocrit can be taken from our ABG report as it is a ‘near patient testing with a formal quality control program in operation’

Yes, ok to use this Hct.

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Lowest PaO2, associated CO2, Fio2 and ‘with respiratory support’ relates to the same ABG and timepoint?

Yes

Dobutamine – only one option/square to complete. Entered ‘NA’ if not on any is that OK?

Also entered NA to other inotropes if not on them

Yes, this is fine. As there are so many inotropes boxes, it is ok to bracket them and put NA alongside.

RS/Acid Base- ‘With Respiratory Support’ there isn’t a ‘NO’ option to tick. If patient is not ventilated for this given ABG what do we enter?

Agree this is not ideal,you can write “No” alongside the box if the patient is not receiving respiratory support. The next version of the CRF will have a ‘NO’ box.

Highest Positive Base Excess – no + results so completed NA into this field. OK?

Yes

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‘Cause of Faecal Peritonitis / CAP – states ‘√ one for each’. Does this mean tick the one that applies as there is no ‘yes’ / ‘no’ option for each

Yes, also, if by any chance there is more than one cause you can tick more than one box for either FP or CAP.

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Also states to ‘‘√ one for each’ but what if there is more than one problem i.e. if patient has had an MI and had valvular disease?

You can tick as many boxes as are appropriate for each category, e.g. you can tick both MI and valvular.

Can you please define:

Major Surgery

Moderate or severe liver disease

Moderate or severe renal disease

These are as defined for APS for Apache. No real strict definitions, but it is for us to use our best judgement to define.

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Guidance notes – systemic anticoagulation. Please confirm what AHF means.

AHF = Automated Haemofiltration (Renal replacement therapy). Corrected in new version of CRF.

Please also confirm that DVT prophylactic doses of Heparin or doses of low molecular weight heparin are not included.

Yes

Actual Scenario;

Patient returned to theatre on day 9 for planned closure of laparostomy wound. Washout performed and abdomen closed, stat dose of Augmentin given in theatre. Spiked a temperature later that day, specific source of infection not documented (possible gut contamination) but started on Tazocin to cover, 5 day course. No + cultures/results from lab. I think the focus may be abdomen post op and ABs were started early as prophylaxis / to cover probable source. It was not a major episode of ICU acquired infection, no marked increase in O2 or inotropes needed so my feeling is that we don’t need to document this under ‘other ICU acquired infection’.

Do you agree?

Yes

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Should we document stat doses of ABs given in theatre immediately prior to ICU admission? E.g. stat dose (and only dose) of Gentamycin given at time of operation that preceded ICU admission.

Yes please, if the data is available. We can tell from time and date that it was given pre ICU, you could also use the comment box to explain if needed.

Should we record ABs given for CAP/FP prior to admission but that were never given in ICU. i.e. ABs were reviewed and stopped on admission to ICU.

Yes please - if the data is available

Do we need to document ABs given in the first 7 days even if not on ICU? i.e. patient discharged at end of day 2 and had a change of ABs on the ward

No, if the patient is discharged and still on antibiotics, tick the antibiotics continued after ICU discharge box on page 21. Don’t worry about collecting data from the patient when on the ward. However if the patient is readmitted to ICU and you have an actual stop date for the antibiotic, please do enter this if possible.

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Other specific therapies used during admission – All our patients are subject to Tight glycaemic control guideline. Should this column be ticked even if patient did not require insulin. What if patient has IDDM and requires insulin but is also septic. Would we tick this box for them?

Yes and yes.

Duration of organ support – please confirm that this applies to the whole admission time not just the first 7 days.

Yes

Leaving boxes empty, i.e. not filled in doesn’t feel right as they usually generate queries for other studies. It would be useful to have a yes and a no option to make it clear that the boxes haven’t mistakenly been left empty.

As there is no option to answer No to a number of questions should we add ‘NA’ next to the box so that it confirms that we haven’t just forgotten to complete it?

Yes that ‘s fine, put No or NA whichever is most appropriate

COMMENTS section under Chest Radiograph. Does this apply to the CXR or for general comments? If for general comments why does this option not appear for day 1?

The comments box is for any comments. Only absent from day 1 as no room on the page. You can always put comments in the comments sections on the other pages, just need to explain which day the comment applies to.

Patient is admitted to ICU, discharged on day 3 then readmitted 1 day later. Do we need to complete any data or treat as a separate admission therefore not complete day 5 or 7 on CRF

The readmission counts as a separate episode, hence you do not need to collect the data

You ask about ‘adequate’ fluid resuscitation beyond day 1. Why (if this is related to Sepsis care bundle?)

This is collected as part of the ‘Bone’ criteria for SIRS/sepsis/severe sepsis/septic shock;Bone RC, Sibbald WJ, Sprung CL, Chest 1992; 101: 1481-1483

We are calculating this along with the SOFA scores for each data collection day.

You only ask for Associated PCo2 for day 1, why?

Only required for Apache calculation (hence day 1 only)

There is a comment under Liver - “*(Warfarin or Heparin in anticoagulant doses)” for each of the days except day 1. Definitions are the same for all days yes?

Yes. Comment only omitted from day 1 because no room on page.

You mentioned about taking only laboratory Haematocrit values. However the lab ones are never entered onto our CIS system despite being reported from the lab. Do we need to transpose them across or are you happy that we just take the ones actually on CIS?

Yes

GP letter.

We are sending the GP letters as it is very likely we will need to contact the GP for the patient follow-up. Copy of the GP letter is in the site investigator file.

Are we looking for adverse events within the first 7 days, for the time they are in the ICU or for the entire 6 months? We presume it is for the period of time in which the patient is in the ICU but we would just prefer to clear this with you.

Adverse events - I can't actually think of anything which will be applicable here as the study is largely observational (except blood sampling), however I think it is reasonable to consider AE's for the ICU stay only. I put this section in the study site investigator file as a 'just in case' but think it is highly unlikely that it will ever need to be completed.

The main part we thought might be difficult to complete was the ethnicity questionnaire. If we are unable to complete this do we just leave it blank and continue?

Yes, that's fine - there are 'not known' boxes within the lists for patient, patient's parents and patient's grandparents. We've found that the best time to get the ethnicity information is usually when you are obtaining consent.

The research nurses hope to be getting consent for the study ourselves so we wondered if you had a form that the PI could sign to say he is happy for us to do this.

Sorry, we do not have a form for this. If this is required for your site maybe the PI (as you suggested) could sign a letter stating that he is happy for you to do this? The research nurses here and at other sites are taking consent. This shouldn't be a problem as long as your PI supports this and you are familiar with the study and protocol