Download Training Slides - PICU Nurses

Investigators: Kusum Menon, Dayre McNally, Katie O’Hearn,
Margaret Lawson, Karen Choong, Lauralyn McIntyre, Hector Wong.
STRIPES PILOT STUDY

A multicentre pilot feasibility randomized controlled
trial

7 participating sites across Canada

Enrollment: 72 patients over 1.5 years

Expected enrollment at CHEO: 12 to 24 patients over 1
year (1 to 2/month)
BACKGROUND
 Insufficient evidence to support use of corticosteroids to treat
pediatric shock
 Also evidence from other populations suggesting potential
harm.
OBJECTIVES OF THE RESEARCH PROGRAM
 To determine the effect of hydrocortisone versus placebo
on clinical outcomes in pediatric patients with fluid
and/or vasoactive infusion dependent shock.
ELIGIBILITY CRITERIA - INCLUSION
Inclusion Criteria
1. Children newborn to 17 years; and
2. On any dose of any vasoactive infusion for at least one
hour but ≤ 6 hours.
Notify on-call research assistant as soon as a
patient with shock is started on any vasoactive
agent.
Research assistant will be on call 24/7.
ELIGIBILITY CRITERIA - EXCLUSION
Exclusion Criteria
1. Known or suspected HPA axis disease;
2. Received more than one dose of systemic steroids in the last 10 days
or any dose of systemic steroids in the last 24 hours;
3. Expected to have treatment withdrawn;
4. Premature infants (<38 weeks corrected GA);
5. Pregnant;
6. Post cardiac surgery;
7. First dose of vasoactive infusion was given >24 hours post PICU
admission
8. Patient is no longer on vasoactive infusion at time of enrolment
and/or are expected to no longer be on vasoactive infusion at the
time of first dose of study drug
Exclusion Criteria con’t
9. Primary cardiogenic shock is strongly suspected (e.g.
clinical signs of heart failure, large heart on chest
radiograph etc.);
10. Spinal shock is strongly suspected (e.g. history and physical
findings compatible with spinal injury and/or mass); and
11. Hemorrhagic or hypovolemic shock is strongly suspected
(e.g. history suspicious of blood or fluid loss).
**Criteria #9 to 11 are based on the clinical judgment of the
treating physician. **
Assist study team with verification of eligibility criteria
RECRUITMENT
Exclusion criteria present.
Patient not eligible.
Patient aged newborn to 17 years with shock is
started on any vasoactive agent in the PICU or
the Emergency Room → Care team notifies study
staff
Study staff will verify inclusion and exclusion criteria
(with assistance from ICU physician)
Patient is eligible
Enrolled using Deferred Consent
Patient must be randomized
within 6 hours of being started
on a vasoactive agent
Patient must receive first dose
of study drug within 8 hours
Randomize
Blood
sample
(3ml)
INTRAVENOUS
INTRAVENOUS NORMAL
HYDROCORTISONE
SALINE PLACEBO
DEFERRED CONSENT
 Approved by REB
 Patients will be enrolled using deferred consent, and informed
consent will be obtained as soon as possible
 Study team will provide ICU staff with a pamphlet to give to
legal guardian as soon as is appropriate
 Poster will be hung by patient’s bedside to state that they have
been enrolled in the STRIPES study
MRP will help study team identify appropriate time to speak
to family about continued consent.
ICU PROCEDURES: STUDY DRUG
*Escalation of Therapy defined as an
increase in vasoactive infusion(s) OR any
fluid bolus(es) including saline, ringer’s
lactate, albumin or blood products for low
blood pressure, elevated heart rate or
signs of poor perfusion
Bolus Dose: 2mg/kg
1 mg/kg q6h until there has been no
escalation of therapy* for at least 12 hours
If following the initial study drug wean, the
patient requires fluid boluses and/or an
increase in vasoactive infusion(s), study
drug should be increased back to
1 mg/kg q6h until they meet stability
criteria again (i.e. no escalation in therapy
for at least 12 hours)
No escalation in therapy should be
determined together with the resident, fellow
or staff physician twice daily during morning
and evening rounds
1 mg/kg q8h until the patient is off all
vasoactive agents for 12 hours
Study drug should be continued for a
maximum of 7 days/168 hours
No wean necessary
ICU PROCEDURES: BLOOD SAMPLE
• A single blood sample will be drawn from patients who have
lines in place OR who are having clinically-indicated blood
work
• Draw: 3ml in red-top tube
• No needle poke just for research sample – no lines/clinicallyindicated bloodwork = no research sample done
• Timing of blood sample: Should be drawn before first dose of
study drug is given
• If access for bloodwork is not available before first dose of
study drug, but becomes available within the first 24 hours
of admission, blood sample should still be drawn
• If 3 ml cannot be obtained, still draw sample
ICU PROCEDURES: BLOOD SAMPLE
• Research assistant will provide a bedside package with
instructions for blood draw and pre-labelled collection tube
• Person who draws the blood sample will complete the
requisition form:
REQUISITION FORM
Complete date
and time of
collection, name
of person
collecting sample
Check off which cryovials
should be filled:
1) If drawn before 1st dose
of study drug, check all 4
2) If drawn after first dose of
study drug, check two
Will be outlined on bedside
instructions sheet
ROLE OF THE ICU/ER MEDICAL TEAM
(NURSE AND PHYSICIANS)
• Notify study staff as soon as a patient with shock is started on
any vasoactive agent
• Assist RA to identify an appropriate time to approach legal
guardian about consent
• Administer study drug according to pre-printed order
• Blood sampling:
o If the patient has lines in place, or is having blood drawn for
clinical reasons, draw additional 3 ml blood
o Blood sample should be prior to initiation of study drug (or
within 24 hours of hospital admission)
ABC & STRIPES
 Patients can be enrolled in both the STRIPES and ABC
study
QUESTIONS?
THANK YOU!
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Participating Sites
Alberta Children’s Hospital
British Colombia Children’s Hospital
Children’s Hospital of Eastern Ontario
CHU Sainte Justine
IWK Health Centre
McMaster Children's Hospital
Montreal Children’s Hospital
Coordinating Centre Contact Information
Study Coordinator: Katie O’Hearn
Children’s Hospital of Eastern Ontario
Email: [email protected]
Telephone: 613.737.7600 ext. 4006