Oral Rehydration Therapy in Burn Patients
关键词
抽象
描述
Primary objectives
- To show that ORT in burns (using Ceralyte® 90) can reduce the total amount of intravenous fluid needed for adequate resuscitation.
- To test the efficacy and safety of ORT in resuscitation of burn patients Secondary objectives.
- To encourage further research on the use of ORT in large thermal injuries and mass casualty situations.
日期
最后验证: | 01/31/2019 |
首次提交: | 08/12/2013 |
提交的预估入学人数: | 04/23/2014 |
首次发布: | 04/27/2014 |
上次提交的更新: | 02/10/2019 |
最近更新发布: | 02/17/2019 |
首次提交结果的日期: | 10/08/2017 |
首次提交质量检查结果的日期: | 02/10/2019 |
首次发布结果的日期: | 02/17/2019 |
实际学习开始日期: | 04/30/2013 |
预计主要完成日期: | 02/28/2015 |
预计完成日期: | 02/28/2015 |
状况或疾病
干预/治疗
Drug: Ceralyte 90
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Ceralyte 90 Ceralyte® will be administered during the first 24-hours post-burn. Fluid requirements will be calculated according to the Parkland Formula with 50% administered during the first 8 hours and the second 50% administered over the next 16 hours. During the first 2 hours IV fluids will be started at the Parkland goal minus 250cc, which will be administered using Ceralyte via oral, nasogastric (NG), or dobhoff tube. ORT and IV fluids will be monitored with additional doses given hourly. Urine output will be monitored hourly and gastric residuals will be monitored every 2 hours, with adjustments made as needed to ensure adequate fluid resuscitation. | Drug: Ceralyte 90 This is a prospective pilot study of patients with moderate-major burn wounds (20-65% TBSA).
Patients who meet inclusion/exclusion criteria will be enrolled in the study upon admission to the Burn Unit.
Fluid requirements will be calculated according to the Parkland Formula (4 cc/kg/% Total Body Surface Area) administered over 24 hours since time of injury.
5. Patients will be monitored according to standard of care.
a. If gastric residuals are >300cc, ORT will be stopped and only IV fluid resuscitation will be used. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Adult patients aged 18-65 years - Partial- to full-thickness burn injuries involving 20-65% of total body surface area (TBSA) Exclusion Criteria: - Presence of inhalation injury - Hypotension or shock - Concomitant serious traumatic injury (i.e. head/ spine trauma) - Gastric Bypass Surgery - Small Bowel Obstruction - Delay in resuscitation >2 hrs. |
结果
主要结果指标
1. Number of Participants With a 20% Decrease in Required IV Fluid. [24 hours post-burn]