小児敗血症性ショックにおけるストレス性ヒドロコルチゾン

基本情報

NCT ID: NCT03401398
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 500
治験依頼者名: Seattle Children's Hospital

概要

SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock. It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).

対象疾患

Septic Shock

介入

Hydrocortisone, sodium succinate(DRUG)

Normal saline(DRUG)

依頼者（Sponsor）

Canadian Institutes Of Health Research (Cihr)(OTHER_GOV)

Children's Hospital Of Eastern Ontario(OTHER)

Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)(NIH)

Canadian Critical Care Trials Group(OTHER)

Jerry Zimmerman(OTHER)

実施施設 (2)

兵庫県立こども病院

Kobe, Japan(RECRUITING)

あいち小児保健医療総合センター

Nagoya, Japan(RECRUITING)