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临床试验/NCT01401634
NCT01401634已完成1 期

Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

University of Southern California2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
80
试验地点
2
主要终点
Change in Blood Sugar

研究概览

简要总结

Diabetes and high blood sugar are extremely common among patients presenting to US Emergency Departments. Intravenous fluids with or without insulin are often used to treat these patients. However, simple, low-cost interventions, such oral hydration have not been studied in this context. Oral rehydration may be better than no therapy at all, which is often what these patients receive in the first few hours when presenting to busy, overcrowded Emergency Department (ED) with long wait times, or in resource-poor environments such as developing countries. The investigators propose a study to see if oral hydration for adult patients presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500 mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients will be given intravenous fluids per our department protocol, while the other half of the patients will be given 2 liters of water to drink over a 1-hour period. Both groups will have their blood sugar measured every 30 mins for 2 hours. The investigators will analyze the data to determine if there is a statistically significant difference in blood sugar between the two groups within 2 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
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

  • Any patient, above the age of 18 years old, presenting to Emergency Department triage with a fingerstick glucose between 250 and 500 mg/dL

排除标准

  • Patients with evidence of DKA (hyperglycemia with ketonuria and abnormal pH or bicarbonate on venous blood gas), HHS, or other critical illnesses requiring immediate medical attention (as determined by ED triage nurses),
  • end-stage renal disease requiring dialysis through an arterio-venous shunt or fistula,
  • abnormal mental status (GCS < 15),
  • unstable vital signs including pulse > 100, SBP < 100, respiratory rate>20, (or any combination of vital signs not meeting these cutoffs but deemed worrisome by the triage nurse) or unable to tolerate oral intake/actively vomiting.
  • Patients who receive IV fluids prior to or during the study period.
  • Patients unable to communicate in English or Spanish.
  • Jail patients will also be excluded.

结局指标

主要结局

Change in Blood Sugar

时间窗: 2 hours

Patients will have their blood sugar checked every 30 minutes for 2 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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