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临床试验/NCT02082717
NCT02082717终止4 期

The Impact of 4% Sodium Bicarbonate Additive During Potassium Chloride Replacement on Pain and Incidence of Phlebitis for Adult Patients in a Medical Surgical Unit: A Randomized Double Blinded Controlled Study

Baptist Health South Florida1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
17
试验地点
1
主要终点
Number of Participants With Indicated Findings

研究概览

简要总结

The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy for adult patients in a Medical/Surgical unit. Using a randomized controlled double blinded experimental study design, patients who are 21 years or older are alert, awake, and oriented at the time of enrollment and have been ordered peripheral intravenous potassium chloride replacement will be recruited from one Medical/Surgical during the first 24-48 hours of their admission.

详细描述

The specific aim of the study is:

Aim 1: To compare patient outcomes (phlebitis, pain at peripheral IV insertion site, frequency of changing IV access, and time for administration) between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Aim 2: To compare number and type of nursing interventions done during peripheral intravenous potassium chloride replacement therapy between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Aim 3: To compare attrition rates and reasons between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • admitted to the medical/surgical unit within the last 24 to 48 hours
  • awake, alert, and oriented times three
  • 21 years old and greater
  • receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or ARNP as part of care and regardless of research
  • potassium level of 3.5 mmol/L or less.

排除标准

  • patients who have been in the medical/surgical unit more than 48 hours.
  • altered mental status defined as not being awake, alert, and oriented times three
  • patients who already received intravenous potassium chloride replacement during the current admission and with the current IV access
  • patients receiving intravenous potassium replacement therapy through a central line
  • patients that are not ordered potassium replacement by physician or ARNP as part of their care while hospitalized.

研究组 & 干预措施

Neut (4%sodium bicarbonate additive)

Experimental

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

干预措施: potassium chloride replacement (Drug)

Neut (4%sodium bicarbonate additive)

Experimental

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

干预措施: Experimental - 4% Sodium Bicarbonate (Drug)

Control

Active Comparator

standard of practice potassium chloride replacement (with no additive)

干预措施: potassium chloride replacement (Drug)

结局指标

主要结局

Number of Participants With Indicated Findings

时间窗: Up to 4 hours

outcomes - phlebitis, pain at peripheral intravenous insertion site, frequency of changing IV access, and time for administration. experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy.

次要结局

  • Number of Participants Nursing Interventions(Up to 4 hours)
  • Attrition Rates(Up to 4 hours)

研究者

发起方
Baptist Health South Florida
申办方类型
Other
责任方
Sponsor

研究点 (1)

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