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
|Condition or disease||Intervention/treatment||Phase|
|Shock||Drug: Hydrocortisone Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone).
Other Name: Placebo (saline solution)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|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|
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H8L1|
|Montreal Children's Hospital of the MUHC|
|Montreal, Quebec, Canada, H3H 1P3|
|Hospital St. Justine|
|Montreal, Quebec, Canada, H3T 1C5|
|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|