跳至主要内容
临床试验/NCT01293500
NCT01293500终止不适用

Goal-directed Resuscitative Interventions During Pediatric Inter-facility Transport (The GRIPIT Trial)

Arkansas Children's Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
230
试验地点
2
主要终点
Incidence of Multiple Organ Dysfunction

研究概览

简要总结

Recent advances in critical care medicine have dramatically improved morbidity and mortality of critical illness. Goal-directed therapy protocols have been instrumental in this change. Goal-directed therapy standardizes the rapid delivery of definitive care in illnesses such as SIRS (Systemic Inflammatory Response Syndrome) and head trauma. Although this treatment approach has been shown to improve clinical outcomes, it has not been widely adopted outside academic medical centers. Further improvement in outcomes of critical illness is likely if goal-directed therapy is utilized early in the course of care. To facilitate this early adoption, goal-directed therapeutic protocols should be developed and implemented by specialized pediatric transport teams. The investigators hypothesize that the institution of goal-directed therapy during pediatric interfacility transport will improve the outcomes of critically ill children.

The GRIPIT Trial (Goal-directed Resuscitative Interventions during Pediatric Inter-facility Transport) will compare outcomes of pediatric SIRS patients before and after the implementation of a goal-directed therapeutic protocol during transport. This will be the first test of goal-directed therapy in the transport environment. Data will be collected on pediatric SIRS patients transported by the Angel One Transport Team at Arkansas Children's Hospital before and after protocol implementation. Outcome measures will include length of hospital stay, length of intensive care unit (ICU) stay, incidence of multiple organ dysfunction syndrome (MODS), and required therapeutic interventions during ICU stay (TISS-28 scores). In addition, NIRS (Near-Infrared Spectroscopy) monitoring will be used as a cerebral and somatic oxygenation trend monitor, to determine its effectiveness as a resuscitation guide for pediatric SIRS during transport. NIRS trends are useful as a surrogate marker for systemic venous saturations, known to decrease with severe SIRS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients transported to Arkansas Children's Hospital by the Angel One Transport Team
  • Age Group: 1 month - 17 years
  • Systemic Inflammatory Response Syndrome (Age-specific SIRS criteria)

排除标准

  • Known or suspected congenital heart disease
  • Known or suspected cardiomyopathy or myocarditis
  • Diabetic Ketoacidosis (DKA) as SIRS-inducing illness
  • Traumatic Brain Injury (TBI) as SIRS-inducing illness
  • Burn Injury as SIRS-inducing illness
  • Patients with known or suspected active hemorrhage

结局指标

主要结局

Incidence of Multiple Organ Dysfunction

时间窗: ICU Admission to ICU Discharge

Computed utilizing PELOD scores.

Required ICU Interventions

时间窗: ICU Admission to ICU Discharge

Utilizing TISS-28 Scores

Hospital Length of Stay

时间窗: Hospital Admission to Hospital Discharge

Subjects will be followed from hospital admission to hospital discharge.

次要结局

  • Changes in cerebral and somatic oxygenation(During Inter-facility Transport (Average))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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