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临床试验/NCT02950753
NCT02950753已完成早期 1 期

Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?

University Medical Center of Southern Nevada1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Mean Lactate Level of the LR Group Compared to the NS Group.

研究概览

简要总结

Lactated Ringer's (LR) solution bolus is commonly administered in the emergency department setting to seriously ill patients. It is also common to obtain blood samples to determine serum lactate levels to aid in the assessment of the patient's degree of illness. This study endeavors to determine if serum lactate levels are affected by LR fluid administration in healthy adult individuals as compared to those who receive Normal Saline (NS). Healthy adult volunteers will be used as subjects so that the illness of hospital patients does not confound the results.

详细描述

Methods:

Approximately 30 subjects will be randomized to either the Lactated Ringer's group or the Placebo group. The study is powered to detect a difference of 0.3mmol/L between pre- and post-treatment lactate levels. All subjects are healthy volunteers over 18 years old. Healthy volunteers are defined as subjects with no acute symptoms who do not meet any of the exclusionary criteria below:

  • Pregnancy or currently breast-feeding
  • Prisoner status
  • Those with any history of clinical conditions associated with fluid overload: congestive heart failure, renal, or hepatic failure
  • Baseline serum lactate level >2.2mmol
  • Baseline creatinine > 1.5 mg/dL

All volunteers will sign a written consent, approved by the Institutional Review Board (IRB). The consent form will discuss the risks and benefits of our study. The benefit of our study is to identify a possible confounder to our current interpretation of serum lactates. By clarifying whether Lactated Ringer's fluid can contribute to measured serum lactate level we hope to improve our care to septic patients and those patients with abnormal vital signs and elevated serum lactate levels in whom the diagnosis of sepsis is being considered. The risks of this study include the possible development of fluid overload state and pulmonary edema. We believe these sequelae would be very unlikely to occur since we are excluding anyone with a history of any clinical conditions associated with fluid overload.

The intended pool of our volunteer subjects will be from residents, attendings, hospital staff, and medical students in the hospital. Only healthy volunteers (as described previously) will be allowed to participate. Volunteer subjects from the hospital will be instructed to only participate after their work shifts or on their days off from work so as not to interfere with their job duties. The consent form will clearly specify that their participation in the study will not impact their academic status or employment. The subjects will also fill out a short data collection form that will have age, gender, known medical problems, medications, and allergies. The subjects will designate their weight in this consent form.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult volunteers
  • 18 years and older

排除标准

  • Pregnancy or currently breast-feeding
  • History of conditions associated with fluid overload: heart, renal or hepatic failure
  • Baseline serum lactate level >2.2mmol
  • Baseline creatinine > 1.5 mg/dL

研究组 & 干预措施

Lactated Ringer

Experimental

Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.

干预措施: Lactated Ringer Solution (Drug)

Normal Saline

Placebo Comparator

Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in Mean Lactate Level of the LR Group Compared to the NS Group.

时间窗: 5 minutes after IV bolus has ended.

Final mean lactate minus initial mean lactate

次要结局

  • Decrease in Bicarbonate Level of the LR Group Compared to the NS Group(5 minutes after IV bolus has ended.)
  • Final Chloride Level Minus Initial Chloride Level of the LR Group Compared to the NS Group(5 minutes after IV bolus has ended.)

研究者

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

Joseph (Tony) Zitek, MD

MD

University Medical Center of Southern Nevada

研究点 (1)

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