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Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study (STRIPES)

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ClinicalTrials.gov Identifier: NCT02044159
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : March 14, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Alberta Children's Hospital
British Columbia Children's Hospital
London Health Sciences Centre
St. Justine's Hospital
IWK Health Centre
Montreal Children's Hospital of the MUHC
Information provided by (Responsible Party):
Kusum Menon, Children's Hospital of Eastern Ontario

Brief Summary:
Approximately 20,000 children per year in North America present to the hospital with severe shock. Children who develop this condition have very low blood pressures and as a result may suffer damage to their internal organs and may even die. Some children with this condition may significantly benefit from the use of steroids but steroids in such patients may also have potential side effects. Therefore it is important to study the use of steroids carefully in these children. The STRIPES research program will examine the effectiveness and safety of steroids in children. Before conducting a large, randomized controlled trial (RCT), a pilot study (STRIPES Pilot Study) will be conducted in multiple sites across Canada. The STRIPES Pilot Study will allow testing of the STRIPES study protocol in a smaller group of patients.

Condition or disease Intervention/treatment Phase
Shock Drug: Hydrocortisone Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study (STRIPES)
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Experimental: Hydrocortisone
Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.
Drug: Hydrocortisone
Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg).
Other Name: SOLU-CORTEF

Placebo Comparator: Placebo
Patients randomized to the placebo arm will receive a placebo solution consisting of normal saline equivalent in volume to the appropriate dose of hydrocortisone. Hydrocortisone and placebo will be identical in appearance, volume and smell as hydrocortisone is made up in normal saline and dissolves completely with no visible precipitate. The dosing regimen will be identical to the hydrocortisone arm.
Other: Placebo
The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone).
Other Name: Placebo (saline solution)




Primary Outcome Measures :
  1. Patient Accrual Rate Over One Year (% of Target Sample Size Achieved) [ Time Frame: 1 year ]
    The total number of participants recruited over the recruitment period to both arms (this was a feasibility outcome that was analyzed for the full cohort and, as stated a priori in the study protocol was not compared between study arms). Our goal is to recruit 72 patients over one year . However, we will consider patient accrual rate to be adequate if we recruit 60 patients from seven sites within this time period.


Secondary Outcome Measures :
  1. 1a. Time to Administration of the First Dose of Study Drug [ Time Frame: 8 hours from starting vasoactive medication ]
    This objective is a measure of protocol adherence. The goal is to have patients randomized within 6 hours, and study drug administration completed within 8 hours of starting a vasoactive medication. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.

  2. 1b. Weaning of Study Drug to q8h When Patient is Hemodynamically Stable [ Time Frame: 7 days ]
    This objective is a measure of protocol adherence. The goal is weaning of study drug to q8h within 12 hours of no escalation of therapy. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.

  3. 1c. Discontinuation of Study Drug When Off All Vasoactive Medications [ Time Frame: 7 days ]
    This objective is a measure of protocol adherence. The goal is to discontinue study drug within 12 to 18 hours of vasoactive medications being stopped. We will consider adherence to the protocol adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.

  4. Number of Patients Started on Open Label Steroids by the Treating Physician [ Time Frame: 7 days ]
    We will consider the number of patients started on open label steroids by the treating physician to be acceptable if it occurs in less than 10% of patients. We will also collect information on the clinical parameters of patients when open label steroids are given.

  5. Time to Discontinuation of Vasoactive Infusions [ Time Frame: Daily during hospital admission (up to 28 days) ]
    The time to discontinuation of vasoactive agents will be used to better estimate the sample size for the full study.

  6. Number of Participants With Incidence of Adverse Events and Mortality in the Full Cohort [ Time Frame: Daily during hospital admission (up to 28 days) ]
    The specific adverse events that will be measured include: severe bleeding, secondary infections and the use of insulin infusions. The incidence of adverse events and mortality rate was measured in aggregate (i.e. the whole cohort) in order to provide a better baseline estimate of these outcomes in our study population.

  7. Percentage of Patients for Whom Blood Samples Are Sent, and Successfully Received and Analyzed in Their Respective Labs [ Time Frame: End of the study recruitment phase (up to 1.5 years) ]
    A total of 3 ml of blood in a red top tube will be collected within 24 hours of hospital admission. Patients with access for blood sampling and for whom consent has been obtained will have blood samples collected. The samples will be separated at each centre, stored until the end of the recruitment period, and then shipped to the principal investigators's centre as per the specific test requirements. The free cortisol and stratification biomarker samples will be batched and then shipped to Cincinnati for analysis at the end of the study. The number of samples collected, and the number of samples successfully received and analyzed at the principal investigator's site and at the Cincinnati lab will be determined at the end of the recruitment phase.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children newborn to 17 years
  • On any dose of any vasoactive infusion for between 1 to 6 hours

Exclusion Criteria:

  • Patients who have known or suspected hypothalamic, pituitary or adrenal disease
  • Patients who are currently receiving steroids for the treatment of shock/suspected shock prior to randomization
  • Patients who are expected to have treatment withdrawn
  • Patients who are premature infants (<38 weeks corrected gestational age)
  • Patients who are pregnant
  • Patients post cardiac surgery
  • Patient who received their first dose of vasoactive infusion >24 hours after PICU admission
  • Patient who is no longer on vasoactive infusion at the time of study enrollment, and/or is expected to no longer be on vasoactive infusion at the time the first dose of study drug will be administered
  • Patients for whom primary cardiogenic shock is strongly suspected
  • Patients for whom spinal shock is strongly suspected
  • Patients for whom hemorrhagic or hypovolemic shock is strongly suspected
  • Patients who were previously enrolled in the STRIPES study
  • Patients who receive a vasoactive agent for reasons not related to shock
  • Physician refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044159


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H8L1
Canada, Quebec
Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Hospital St. Justine
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Alberta Children's Hospital
British Columbia Children's Hospital
London Health Sciences Centre
St. Justine's Hospital
IWK Health Centre
Montreal Children's Hospital of the MUHC
Investigators
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Principal Investigator: Kusum Menon, MD, MSc Children's Hospital of Eastern Ontario
Study Chair: Karen Choong, MB, MSc McMaster Children's Hospital
Study Chair: James D McNally, MD, PhD Children's Hospital of Eastern Ontario
Study Chair: Lauralyn McIntyre, MD, MSc The Ottawa Hospital
Study Chair: Margaret Lawson, MD, MSc Children's Hospital of Eastern Ontario
Study Chair: Hector Wong, MD Children's Hospital Medical Center, Cincinnati
Study Chair: Tim Ramsay, MSc, PhD Ottawa Hospital Research Institute
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kusum Menon, Senior Investigator, CHEO Research Institute; Associate Professor, University of Ottawa; Physician, Division of Critical Care, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02044159    
Other Study ID Numbers: STRIPES-Pilot
First Posted: January 23, 2014    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Kusum Menon, Children's Hospital of Eastern Ontario:
Hydrocortisone
Pediatrics
Adrenal Insufficiency
Additional relevant MeSH terms:
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Shock
Pathologic Processes
Hydrocortisone
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents