FAQs

 Wisdom FAQs

Regulatory

  1. Do all Co-Is/Sub-Is have to sign the COI?

No. Only the PI at each site needs to sign the COI.

 

  1. For the REDCap attestation for previously completed REDCap training, is there a specific format or form to complete?

No. Write a NTF stating when the training was previously completed and that you have been a regular REDCap user since that time, sign and date. This NTF should be uploaded to the Study Personnel Training Log.

 

Screening:

  1. Can some of the eligibility criteria in the screening log be left blank if the patient is found to be ineligible based on another criteria?

Yes. For example, If the participant meets exclusion criteria #2 (end stage kidney disease) then it may not be necessary to discuss the inclusion criteria #4 (expected to survive and receive CRRT for duration of >/ 48 hours) with the treating physician and therefore inclusion criteria #4 should be left blank.

 

Eligibility:

  1. The patient was initially eligible when screened. Prior to approaching for consent, their eligibility changed, should they be included in the ‘eligible not enrolled’ category?

No. In the MOP on page 22, there is a statement, "If a contraindication to eligibility occurs between the signing of the ICF and enrollment through REDCap, the participant must be deemed ineligible and not enrolled into the study." If the patient became ineligible even before consent was obtained then would not be entered into the REDCap database as ‘eligible not enrolled’.

 

  1. For the exclusion criteria, ‘End-stage kidney disease receiving maintenance dialysis’, does the maintenance dialysis refer to out-patient, in hospital (current admission) or both?

This refers to patients who are receiving chronic dialysis, by any modality (e.g., IHD or PD), as outpatients on a regular schedule.

 

  1. Can patients with only one kidney be enrolled?

Yes.

 

Treatment/Study Visits:

  1. Do participants need to be contacted for the Day 30 & Day 90 outcome assessments?

If participants are still in hospital at Day 30 &/or Day 90, then data can be obtained from their medical records. If participants have been discharged from hospital, then data may be obtained from their medical records, if available, or by contacting the study participant via telephone. An in-person visit is not required.

 

  1. Should the intervention be given as long as CRRT is prescribed or until ICU discharge? (i.e if still on CRRT at time of ICU discharge do they stay on study?)

Intervention is given until: death, transition to IHD, discontinuation of CRRT for recovery or ICU discharge. Once they are discharged from ICU they can be taken off the study intervention even if still on CRRT.

 

Assessments:

  1. Baseline serum creatinine: In the MOP and CRF it states that it should be the 'closest outpatientvalue prior to the present hospitalization'. For participants that come into the ER first and a serum creatinine value is obtained there before they are admitted to the hospital, should this value be entered or should it be a value before this ER visit?

         Ideally, an outpatient value, so before the ER visit. But use the following approach:

  1. Lowest SCR as outpatient within the last 365 days,
  2. Lowest SCR from index hospitalization/pre-ICU,
  3. Lowest SCR while in the ICU.

 

  1. For the APACHE II and SAPS III, temperature is required. Does the temperature obtained either axially or orally need to be adjusted for core body temperature?

No. Use the temperature obtained by whatever means. No need to adjust to core body temperature.

 

  1. What are the normal ranges for the values entered for the SAPS III and APCHE II calculations?

Use your own site's normal ranges for lab tests for the SAPS III parameters and then assess the lowest or highest values based on those that are the furthest outside the normal range.

 

Adverse Events:

  1. Labs showed that the HCO3 was out of normal range but the patient had stopped CRRT three days prior. Is this an AE?

         No – it is not an AE since the patient was already off CRRT.

 

REB Questions:

  1. Please comment on why there is no DSMB for this study.

This is a pilot feasibility study targeting enrollment of 100 patients. For this phase, all safety events will be reviewed by the Steering Committee. A formal DSMC will be formed for the next phase of study. 

 

  1. Please comment on why the participants who fail the lower dose regimen are not simply removed from the study and changed to standard of care treatment.

In general, patients receiving CRRT, including standardized order set prescription and monitoring while receiving therapy are highly protocolized. This is the baseline standard-of-care. The trial protocol has integrated a mitigation strategy for those allocated to the low-dose. This pilot trial aims to assess and understand the feasibility of this low dose-intensity prescription. Following a period of stabilization, this includes a mitigation algorithm to modify the prescription and dose-intensity, as indicated, and adjust the therapy for selected patients if needed. If patients are perceived to require transition to higher dose-intensity or prolonged standard dose-intensity, based on the MRP or ICU team discretion, this is permitted. This will be vital to understand for the trial feasibility. As such, we would recommend that patients are not "simply removed". This would be counter to performing a pilot RCT. Patients can certainly be transitioned and remain in the trial, where data on the dose prescription can be evaluated and used to inform feasibility, including patients who are transitioned to longer durations of standard therapy. Moreover, as in any clinical trial, the MRP and ICU team could remove a patient from the trial if there is a perception that their continued participation is not in their best interest.

 

CRF Completion:

  1. The patient was eligible for WISDOM but was an international student. As an office rule international students are not usually enrolled due to insurance reasons. Should they still include him in the REDCap records since he was eligible but not enrolled? 

 

If so, on the CRF the only options for why they were not enrolled are "consent not given" or "clinician refused." This patient doesn't really fit in either category. So how should we include him in the database?

It would be a reason for clinician refusal - due to fulfilling trial eligibility but the physician declining due to being an international student.

 

  1. Under the physiologic parameters at baseline serum ionized calcium is requested. Is the pH normalized value OK to use?

Yes

 

  1. Is there another term for 'ultrafiltration' in the EMR? Can you clarify what value this should be?

This may be listed as fluid removal per hour.

 

  1. In the daily worksheets, we ask for serum base excess. Is the blood gas value OK to use?

Yes – either the arterial or venous blood gas value is fine to use.

 

  1. In the daily worksheets we ask for serum pH and HCO3, but they only have them from the arterial blood gas. Is this OK to use?

Yes

 

  1. For participants that start CRRT before they are randomized, in the Day 0 worksheet, is the CRRT duration to be entered only the time they are on CRRT from time of randomization? (From the MOP: 'For participants already receiving CRRT at time of randomization, Day 0 represents the time from randomization to the end of that ‘ICU’ day.')

Yes – only enter CRRT duration from time of randomization in Day 0 worksheet.

 

  1. For the labs (urea, Mg, etc) on Day 0, do these have to be values obtained after randomization? At least one participant’s labs were done before randomization and not again until Day 1, so can the values collected before randomization be used as the Day 0 values?

Yes - ICU labs are traditionally done first thing in the morning. If a patient gets randomized at 11 am on Mon Mar 3, the Day 0 labs can be those from the morning of March 3, even if they are technically prior to randomization.

 

  1. For serum base excess, there are multiple values collected in a day but only one field to enter a value. Should this be the max value, the min value or an average? Should we change the database so there is a field for min value and a field for max value?

It should be most extreme value; greatest deviation from normal. For Day 0 can be from pre-randomization, if needed.

 

  1. For blood flow rate (ml/min), if there are multiple different values collected in a day because the participant's blood flow rate is fluctuating, how do they report this in REDCap? As an average blood flow rate for the day?

         Enter the highest blood flow recorded on the chart for that day.

 

  1. For participants that start CRRT before they are randomized, in the Day 0 worksheet, are the prefilter-hemofiltration, post filter-hemofiltration and dialysate values for before randomization to be included? Or do they only calculate the values from time of randomization onward?

         Capture the values from time of randomization onwards.

 

  1. For this study, when do we consider a patient has been admitted? For example, AHS does not consider going to the ER or OR as a hospital admission, so if they go from the ER to OR and then to ICU, do we enter the ICU admission date and time as the date of admission to the hospital?

         Yes. Follow your institution’s policy on date and time of admission to hospital and ICU.

 

  1. For the APACHE II score, do the FiO2, PCO2, PaO2, PO2 values all have to be from the same time point or just the worst recorded prior to randomization?

This can be from any time in the 24 hours prior to randomization and they do not need to be at the same time point.

 

  1. The protocol states that if there is an interruption of more than 6 hours that the participant has to have a 6-hour period of CRRT at standard dose to restabilize before going back on the study allocated dose. One of the participants assigned to standard dose had an interruption longer than 6 hours, so for the time in study allocated dose calculation for that day, do we subtract 6 hours from the time that they were on the standard dose after the interruption since in theory that should have been their restabilization period before going back on the study allocated dose? 

         No – include the period of restabilization in the time in study allocated range. This is done per the protocol instructions so should be included as part of their time in the study allocated range. This is also true for participants in the low dose range. This will be changed in the REDCap database to ‘time in protocol adherent dose range’ for clarity.

 

Example: If in a 24-hour period, the participant is off CRRT for 7 hours due to a surgery and then does a restabilization period of 6 hours, the most they would be in the study allocated or protocol adherent dose range for that 24-hour period is 17 hours (assuming no other events occur that require interruption of CRRT or a change outside the range specified by the protocol).

 

  1. For a participant that has already been on standard dose for 12 hours or more at time of randomization, but then was not immediately put onto the study allocated dose, is the study allocated CRRT initiation date and time, the time that they actually were switched to the study allocated range or the time of randomization?

This should be the time their dose is changed from standard of care, even if it is not quite within the required range. For example, if a participant is assigned to the low dose range and at randomization the dose is lowered but isn’t quite in range it is still protocol adherent because it was lowered and the time of this dose change should be entered.

 

  1. When is the ultrafiltration value negative?

         The value for ultrafiltration in the Daily Worksheets will be positive if more fluid has been removed from the participant’s body than was put in. The value for ultrafiltration will be negative if more fluid is retained in the participant’s body than was put in.

 

  1. For the time in allocated dose range field, is there a percentage outside the range that they can deviate and still be considered within the range? For example, if the participant is in the standard dose range (25-30 mL/kg/hr) and has an hourly rate of 24.9 mL/kg/hr is this considered in range or out of range.

         This would be considered out of range. There is no percentage outside the range that they can deviate and still be considered in range.

 

  1. For the ultrafiltration data, when should it be entered as a positive value and when should it be entered as a negative value?

Fluid retained would be a negative value and extra fluid removed from the body should be entered as a positive value in the CRF. If more fluid is retained by the participant than was removed, in the REDCap CRF enter the value with a negative sign (i.e. ‘-2000’) in the ultrafiltration field.

 

  1. If a participant starts CRRT and then stops CRRT for more than 24 hours, how should the days when no CRRT was given be entered in the study database?

Include the days when the participant is not receiving CRRT in the database by entering '0' for 'CRRT duration' in the Daily Worksheet. Fill in any other fields such as the urine output, lab results collected that day, and details about ventilation, transfusions and supplementation that are available. 

 

For example, a patient received CRRT for the first five days, then received CRRT for less than an hour on the sixth day, didn't receive CRRT for 2 days (7th and 8th days) and was then restarted on the 9th day. In this example, there would be a ‘Intervention – CRRT Treatment Day 0’ CRF, then ‘Intervention – Daily Data Worksheet’ CRFs for Days 1 – 9 and on-going. For the Daily Worksheet for Days 7 & 8, enter '0' for the 'CRRT duration' field, enter the other data for fields not related to dialysis and then change the form status to 'Complete' and save the CRF.

 

  1. On the Prerandomized Acuity and Organ Dysfunction CRF, under Oxygenation, do we have to enter both the PO2 and PaO2 values? In some cases, they may be the same value.

Yes – please enter both values even if they are the same. The PO2 value is used to calculate the A-aDO2 value for the APACHE II score and the PaO2 value is used in the SAPS III scoring.

 

  1. In the SAPS III scoring, what does mechanical ventilation refer to?

It means invasive mechanical ventilation. Non-invasive mechanical ventilation is not considered mechanical ventilation in the SAPS III scoring.

 

  1. Information on multivitamins is collected on the Daily Worksheet. Is a combination of vitamins (each administered separately) considered a multivitamin, or does it need to be one pill/tablet that contains multiple vitamins?

A combination of supplements can be considered a multivitamin.