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临床试验/NCT02404597
NCT02404597撤回不适用

Non-invasive Cardiac Output Monitoring in Patients With Burn Injuries

Emory University2 个研究点 分布在 1 个国家开始时间: 2018年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Rate of pressor use

研究概览

简要总结

The purpose of this study is to describe the use of non-invasive cardiac output monitors (NICOM) in patients with burn injuries and to develop a protocol for NICOM in a burn unit.

详细描述

Appropriate fluid resuscitation in the first 24 hours after a burn injury directly influences patient outcome and morbidity. Currently, there is some controversy surrounding the over and under-resuscitation and endpoints of resuscitation using older fluid resuscitation formulas in patients with burn injury. The NICOM has been used in the resuscitation of patients with sepsis. The NICOM will be used in patients with burn injury to determine the patient's fluid responsiveness and the need for additional fluid boluses versus medications to increase the patient's blood pressure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Burn greater than 20% TBSA (total body surface area)

排除标准

  • Burn less than 20% TBSA (total body surface area)

研究组 & 干预措施

NICOM

Experimental

Subjects with burns greater than 20% total body surface area (TBSA) will have a NICOM placed on them after the first 24 hours of admission if subject has an episode of hypotension (mean arterial pressure < 65 or a systolic blood pressure < 90mmHg). The NICOM will generate a number that reflects stroke volume of the heart. If the number is greater than 10 percent, subject will be given a bolus of crystalloid fluids. If the number is less than 10 percent, subject will start a medication to raise the blood pressure.

Physicians may also use traditional endpoints of resuscitation include base deficit values and urine output goals of 0.5cc/kg/hr as indications of adequate intravenous fluid resuscitation.

干预措施: NICOM (non-invasive cardiac output monitor) (Device)

Control

No Intervention

This is a retrospective comparison control group of patients with burns greater than 20% total body surface area (TBSA) admitted to the hospital from 7/1/2014-12/31/2014.

结局指标

主要结局

Rate of pressor use

时间窗: Duration of hospital stay, an expected average of 30 days

Defined as number of subjects that required pressor support (administration of cardiovascular supportive agents)

Total volume of fluid given

时间窗: 24 hours

The total volume of fluid given to the subjects in the first 24 hours

次要结局

  • Rate of pulmonary edema(Duration of hospital stay, an expected average of 30 days)
  • Rate of acute renal failure(Duration of hospital stay, an expected average of 30 days)
  • Length of stay in intensive care unit (ICU)(3 months)
  • Length of hospital stay(3 months)

研究者

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

Rachael Williams

Associate

Emory University

研究点 (2)

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