跳至主要内容
临床试验/NCT02568189
NCT02568189终止不适用

Randomized Controlled Trial of Inferior Vena Cava Ultrasonography in the Management and Disposition of Pediatric Patients Undergoing Evaluation for Sepsis and Dehydration

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015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
112
试验地点
1
主要终点
Vascular Access Point

研究概览

简要总结

Conduct a randomized, controlled trial looking at how the use of ultrasound analyzing the inferior vena cava impacts the management and outcomes of pediatric emergency department patients undergoing evaluation and treatment of sepsis and gastroenteritis associated dehydration.

详细描述

Ultrasound is a widely accepted and highly useful clinical tool. It carries the additional advantage of being rapid, painless and non-radiating. It has long been used to assess cardiac output and vascular pathologies. More recently emergency and trauma clinicians have been using it to assess hydration status, shock/sepsis states and fluid responsiveness. Using sonography to look at the inferior vena cava gives clinician a rapid view of vascular collapsibility that has been previously demonstrated to correlate with mean arterial pressure (MAP) and central venous pressure (CVP). Previously, Jones et. al. completed an randomized controlled trial (RCT) in adults greater than age 17 evaluating the goal directed utility of early versus delayed inferior vena cava sonography for patients presenting with non traumatic hypotension to the emergency department. This study found improved outcomes and more accuracy in diagnostic etiology in those undergoing immediate IVC imaging. The study conducts a randomized controlled trial of IVC Ultrasonography in pediatric patients 0-21 year of age.

Patients admitted to the Emergency Department and triggering triage STOP SEPSIS ALERT (based on triage vital signs and chief complaint), vomiting requiring zofran or diarrhea with concern for dehydration/hypovolemia, the treating physician believes would benefit from intravenous fluids, will be eligible for inclusion into this study. The "treating physician" refers to one of the Pediatric Emergency Medicine attendings or fellows, listed as co-investigators. Only if and when a patient or parent expresses interest in participating in the study, the attending or fellow caring for the patient will determine if the patient is eligible. If the patient is eligible, and has no criteria that would exclude them from the study, written informed consent will be obtained from the guardian and assent will be obtained in children > 7 years old. The patient will be enrolled in the study and randomized to either the immediate ultrasonography group (Ultrasound (US) of the Inferior Vena Cava (IVC) first before the clinician fully assesses the patient and places rehydration orders) or the control group (US at 15 minutes into the assessment and management of the patient). The goal will be to assess how the use of ultrasound impacts clinical management and outcomes in patients presenting to the pediatric emergency department with sepsis and dehydration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Trigger triage STOP SEPSIS ALERT (based on triage vital signs and chief complaint)
  • Present with vomiting requiring Zofran
  • Present with diarrhea with concern for dehydration/hypovolemia

排除标准

  • Unstable patients with life-threatening injuries who require ongoing resuscitation
  • Patient undergoing traumatic resuscitation

结局指标

主要结局

Vascular Access Point

时间窗: Day 1

For sepsis arm, Secured second vascular access point- type (Interosseous (IO), second Intravenous (IV), central venous (CV) access) within 15 min of physician evaluation

Type of Re-hydration

时间窗: Day 1

Type of re-hydration: oral vs. intravenous at the time of disposition from the Emergency Department (ED)

Normal Saline Bolus

时间窗: 60 minutes

For sepsis arm, 60 ml/kg Normal Saline bolus administered within 60 minutes

Antibiotic Use

时间窗: 60 minutes

For sepsis arm, antibiotic given within 60 min

次要结局

  • Survival to Hospital Discharge(30 days)
  • Left Ventricular Function(Day 1)
  • Source of Sepsis(Day 1)
  • Disposition Status(Day 1)
  • Length of ED Stay (From Sepsis Alert to Admission/Discharge Order Entry)(Time between emergency department registration and disposition (admit, transfer or discharge))
  • Return ED Visit for Same Illness Within 48 Hours(48 hours)
  • 30 Day Mortality(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James W Tsung MD MPH

Associate Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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