The CHiP trial

Frequently Asked Questions

General questions

Date format: D D / M M M / Y Y Y Y ?

When entering dates, use the above format e.g. 0 1 /J A N / 2 0 0 8

If a patient no longer requires PICU care and is moved to the HDU within the same ward area, should they be effectively discharged from this part of the study and the collection of CHiP CRF data discontinued?

If a patient is downgraded to HDU care or discharged from PICU before day 30, data collection stops on the day of downgrade/ discharge. Day 30 data and 12 month follow up data should be collected according to the study protocol. All SAE’s should be followed up until resolved

The parents have withdrawn their child from the trial.  What do we do with the data we have already collected?

This data is very useful to the study, but we would need to have the parent’s permission to use it, however there is no new consent form for them to sign. They should be asked by a member of the research team and a note to record this conversation should be added to the original consent document and the medical notes. If the parents do not want the data to be included in the study, it should be destroyed.

My patient has just been entered into the CHiP Trial and I have taken a waist circumference measurement.  Where do I document it?

The waist circumference should be measured at the umbilicus and documented according to local practice - on the PICU observation chart as abdominal girth or in the medical notes as a nursing entry.

There is a patient who matches all the eligibility criteria except he/she has no arterial line.  Can we consent him/her for the study anyway, and then put an arterial line in after randomising?

The patient needs an arterial line in situ before being randomised into the CHiP Trial.  They would not be eligible to enter if the doctors were unable to site one.

The inotropes of a patient in the CHiP Trial have been stopped; do they need to be taken out of the Trial?

No, they do not need to be taken out of the CHiP Trial as long as at the point of randomisation it was anticipated they would be receiving them for at least 12 hours.

Should we use special insulin for a patient in the trial?

No, the usual Actrapid insulin vials will be used and will be kept in the same fridge as the ward stock of insulin. The MHRA have clarified that Actrapid vials should be for single patient use and labelled accordingly. The batch number must be recorded on the prescription chart at the point of administration.
( Multidose vials for different patients can be used, but only if a risk assessment regarding the risk of cross contamination has been carried out.)

The parents of a child previously gave consent for their child to participate in the CHiP trial, but now want to withdraw their child from the CHiP Trial.  What do I do?

You must explain to the parents that they are entitled to withdraw at any time.  You would need to contact the Consultant on-call (or designee) and ask them to talk to the parents. The child would be taken out of the study after a discussion with the parents.  It should be highlighted that their child may continue to be treated with insulin if it was thought appropriate for their care as it is standard practice for hyperglycaemia.  
Permission from the parents would be needed to use any study data already collected.

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Administration of study drug and related questions

Is peripheral or central access advised for the administration of the insulin infusion?

Either is fine to use.

When starting insulin, do we encourage nurses to bolus down the line to ensure delivery for when the blood glucose is checked 30 minutes later?

No, never bolus insulin.

The cut off for starting insulin. We start it if the blood glucose is above 12.0? i.e. 12.1 or is 12.0 included?

For the normal control arm, commence the insulin infusion if the BG is 12.1 or greater (>12) on two measurements at least 30 minutes apart.

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Enrolment issues

My patient is 16 years old exactly, is he/she eligible to enter the study?

No.  The patient must be less than 16 years.

I think my patient is eligible to enter the CHiP study.  None of the PICU consultants or research team are available to obtain consent. Can I talk to the parents and gain their consent to enter the child into the study?

You can explain the study to the parents if you have had some training and feel confident to do so. (depending on the agreed arrangements for obtaining consent at your study site) You should also explain that a member of the PICU research team will discuss the trial in more detail and will ask them for written consent before being able to participate. The parents will also be given an information sheet that should help them to decide.
You should not obtain written consent for a child to enter the CHiP study without the appropriate training

Does my patient meet the entry criteria if they are receiving less than or equal to 5mcg/kg/min of dopamine or dobutamine?

Yes, but only if you anticipate that they will receive this dose or greater for more than 12 hours.

My patient matches all the inclusion criteria to enter the CHiP trial, but they are day 5 of their PICU admission.  Are they eligible to enter?

Yes, they are eligible to enter up to and including day 5 of their PICU admission.  However they should be entered into the study as soon as they meet study criteria.
(Day 1 of the PICU admission is considered the first day of the admission up to 23.59 hours of that day)

The parents do not speak English.  Can we use another family member to translate so that the parents can consent to entering the trial?

No, a professional face-to-face translator should be asked to talk to the parents. Consent would be appropriate only if it were felt that the parents had received enough information and were making an informed choice.

How do I know if my patient has been entered into the study? and which group - Normal Control Group or Tight Control Group?

If the parents of a child have given consent for their child to participate in the CHiP trial, the medical notes will contain:

  1. A copy of a completed consent form,
  2. A printout from the website that will tell you which group the child was randomised into
  3. A yellow sticker on the front of the notes or just inside the cover of the notes (depending on trust procedure) to indicate that the child has been entered into a clinical trial.
  4. A white sticker in the medical notes documenting the date and time the consent was obtained.
  5. A blue sticker clearly documenting the time of randomisation into the control arm or a green sticker clearly documenting the time of randomisation into the tight arm will be place in the medical notes.

How do I randomise a patient into the CHiP trial?

The CHiP research site file contains instructions on the randomisation process. You may find a shortcut to this website on the PICU or other designated computers. (The web address is not included here for reasons of security!)

The randomisation website is not working. What can I do to randomise a patient into the CHiP trial?

What does ‘invasive ventilation’ mean?

‘Invasive’ means the patient must be intubated with an Endo Tracheal Tube (ETT) or a tracheostomy tube.
‘Ventilation’ means the patient must be on a ventilator receiving intermittent positive pressure ventilation i.e. BIPAP, HFOV.  CPAP is not considered to be mechanical ventilation.

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Monitoring the patient

The arterial line of a patient in the trial has fallen out.  Do they need a new arterial line inserted or can we just use finger pricks to obtain blood glucose measurements?

The inclusion criteria for the study states that an arterial line must be in situ. However, if the arterial line stops working or falls out, for safety reasons, the blood glucose level can be measured using finger pricks until the arterial line is replaced. If there is no clinical reason to re-insert an arterial line and it is considered inappropriate to continue to measure blood glucose levels using finger pricks then withdrawal from the trial should be considered. If in doubt telephone the CHiP helpline 07854980072

Can I use the central venous line to take blood glucose measurements?

No, central venous sampling must not be used.  You should use the arterial line for sampling, but if you are unable to access the arterial line, then for safety reasons, a finger prick can be used for blood glucose measurements.

What if the patient is no longer receiving insulin and we have no arterial line to sample the BD blood glucose levels?

Central venous lines cannot be used for blood glucose sampling at any time. However, a peripheral venous line CAN be used if you can be sure that no glucose containing fluid has been infused through it.
If a lack of IV access prevents the collection of blood for this data point and no ‘routine’ finger pricks are being done, then it would be acceptable to record a blood glucose level taken at any time point and record the time it was taken in the comments section of the CRF, but only if it can be verified that it had no contact with glucose solutions.

What device can I use to measure the blood glucose?

Whatever is normal practice for your unit - it is acceptable to use either the bedside glucometers or the blood gas machine. Differences in readings between blood gas machines and glucometers have been noted so try to use one machine consistently.

If the blood glucose begins to climb again after the insulin infusion has been stopped (having followed the flowchart), should I restart the insulin at the rate at which it was running before it was stopped?

No.  You need to go back to the top of the flowchart and follow the initial start-up regime.  This means for the normal Control Group that you would need 2 separate blood glucose measurements > 12 mmols at least 30 minutes apart before you restart the insulin.  For the Tight control group, you would need to start insulin as soon as the BG >7mmols.

Do I have to stop the insulin infusion if the enteral feeds have been stopped for a rest period?

You do not have to stop the insulin infusion, but use a common sense approach.  When you stop the enteral feeds, consider what the blood sugar is and what other glucose the patient is receiving. You would then need to ANTICIPATE a change in blood glucose before deciding how to adjust or to stop your insulin.  

I have calculated that the insulin rate should be 0.37 ml/hr but our infusion pumps do not allow that many decimal places.  Do I round up or down?

You round up if the last number is > 5.  Therefore 0.37 ml/hr would be rounded up to 0.4 ml/hr.
Round down if <5 e.g. 0.12 ml/hr = 0.1 ml/hr.

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Incidents to report

I am the Consultant on call and am not sure if I need to report an incident that has occurred to the Chief investigator/Lead Study nurse?

You need to decide if the incident was serious or not by referring to the CHiP Adverse Events reporting flowchart. If in doubt always call the CHiP helpline 07854980072 for advice.

A child in the CHiP trial required a bolus of glucose for a blood sugar <2.5 mmol/l.  Do we need to let the Chief investigator/Lead study nurse know?

Yes, it is a Serious Adverse Reaction and should be reported within 24 hours of the event.
 If in doubt always call the CHiP helpline 07854980072 for advice.

The nurse of a patient in the CHiP trial forgot to do a blood glucose measurement and the blood glucose dropped to < 2.5 mmol/l thus requiring a bolus of glucose. Do we need to report the incident?

Yes. This would be classified as a Serious Adverse Reaction and needs to be reported within 24 hours.
A Trust Incident Reporting Form should also be completed according to your local practice.

A blood sugar measurement was not taken within the timescale suggested in the CHiP insulin flowchart as he/she was too busy.  The blood sugar was within a safe range when a blood sugar was eventually taken.  Do we need to report this as a trial adverse incident?

No, you do not need to report this as a serious adverse event but you may need to follow your trust incident reporting procedures if it is appropriate.

The potassium level of a patient in the CHiP trial has dropped to 1.9 mmol/L.  Do we need to report it to the Chief Investigator/ Lead study nurse as a Serious Adverse Reaction?

Yes - But only Potassium levels < 2.0 mmol/L should be reported as a Serious Adverse Reaction. The Consultant on call or designee should decide if it is related to the Actrapid infusion and ensure that the CHiP Trial Adverse Event assessment and reporting procedures are followed.

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Data collection issues

Collection of baseline data- the nearest data point after randomisation is greater than 24hours, should I use this result?

Try to collect all data as close as possible AFTER the time of randomisation. But if the nearest data point is more than 12 hours after randomisation, record the data point as ND (data missing Not Done). In this instance, if data is available from the 6 hour period preceding randomisation, it would be acceptable to use this.

How accurate does the Insulin infusion rate in Units/kg/hr, Intravenous carbohydrate and calorific intake data collection need to be?

Record the amount calculated to one decimal place. This can be rounded up or down as appropriate you round up if the last number is > 5. Therefore 0.37 Units/kg/hr would be rounded up to 0.4 Units/kg/hr.
Round down if <5 e.g. 0.12 Units/kg/hr = 0.1 Units/kg/hr

Do I score the maximum PELOD score for a patient that dies?

No, if you are required to record a PELOD score on the same day that a child dies, use all data up to 2 hours prior to the time they died.

If a patient is transferred from another PICU and is eligible for CHiP, is the first day of admission to the previous PICU documented as the date of admission to PICU?

No, the date the patient was admitted to the current PICU is recorded as the PICU admission date on the CRF and screening log.

If our study hospital does not have a separate HDU from our PICU, how should we determine when a patient is effectively discharged to HDU and when should we stop collecting the daily hospital data?

The daily hospital data collection stops when the patient is physically discharged from the PICU or at the point a patient is considered an HDU patient. If your unit is a mix of PICU and HDU patients then local practice for determining an HDU status is acceptable, this may be when a patient is >6hrs post extubation.

Should the administration of oral / NG /NJ antibiotics be documented in the hospital data page of the CRF?

No, when recording whether antibiotics were administered on the hospital data page of the CRF, record only if parental antibiotics were administered.

Should the administration of pump blood be recorded in the CRF as a red cell transfusion?

When recording the number of red cell transfusions do not include any transfusion using pump blood given on return to the ward from theatre.

How flexible is the timing of the 06.00hr and 18.00hr blood glucose measurements in the hospital data page of the CRF?

It is acceptable when recording blood glucose measurements at 06:00 and 18:00 on the hospital data page of the CRF to use the nearest blood glucose recorded within 3 hours prior to or 3 hours post these specified times.

If a patient is discharged from the PICU/CICU, but readmitted to the PICU/CICU after 24 hours and within the 30 day study period. Should we resume collecting the hospital data of the CRF?

No, if a patient has been formally discharged from the PICU/CICU, the hospital data of the CRF is permanently discontinued. However continue to collect transfer data up to day 30 and report any SAE’s within the time period specified in the SOP for adverse event reporting.

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