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

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.

Conditions

• Shock

Interventions

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

Placebo

The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone).

Sponsors & Collaborators

• Alberta Children's Hospital

  collaborator OTHER

• British Columbia Children's Hospital

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Montreal Children's Hospital of the MUHC

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  lead OTHER

Principal Investigators

• Kusum Menon, MD, MSc · Children's Hospital of Eastern Ontario

• Karen Choong, MB, MSc · McMaster Children's Hospital

• James D McNally, MD, PhD · Children's Hospital of Eastern Ontario

• Lauralyn McIntyre, MD, MSc · The Ottawa Hospital

• Margaret Lawson, MD, MSc · Children's Hospital of Eastern Ontario

• Hector Wong, MD · Children's Hospital Medical Center, Cincinnati

• Tim Ramsay, MSc, PhD · Ottawa Hospital Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Canada

Study Locations