跳至主要内容
临床试验/NCT02497742
NCT02497742已完成不适用

Once Versus Twice Daily Electrolyte Monitoring in CHF; a Study Monitoring Electrolytes in Congestive Heart Failure Patients Being Actively Diuresed in Hospital

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Composite time spent in ideal potassium range

研究概览

简要总结

Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University Medical Center. However, it is unclear how often the second BMP each day is acted on. the investigators project aims to answer a few fundamental questions about the need for twice daily labs in patients hospitalized with acute/subacute-decompensated congestive heart failure who are being actively diuresed.

详细描述

Background: Over 5 million Americans are currently suffering from heart failure, resulting in over 1 million hospital admissions each year. Heart failure hospitalizations are one of the most expensive medical problems facing Americans today]. Admissions for acute decompensate heart failure exacerbations are managed medically through oral and intravenous (IV) diuretics. Side effects of diuretics are well established, the most common of which is metabolic derangements, more specifically alterations in levels of potassium . Clinical manifestations of hypokalemia and hyperkalemia are most commonly muscle cramps and clinically insignificant arrhythmia. The most concerning manifestations of hypo and hyperkalemia include symptomatic arrhythmia, myalgia, and more rarely rhabdomyolysis. Active use of diuretics requires monitoring of serum electrolytes to prevent clinically significant derangements in potassium. The frequency of monitoring required to prevent these events has not been established. Monitoring is thus provider dependent. At our single large academic medical center monitoring frequency ranges from 1-2 times daily on average. In this trial we will determine whether twice-daily electrolyte labs result in less frequent clinically hypo or hyperkalemia. We will also investigate a multitude of other outcomes including potential cost savings by reduced laboratory test ordering.

Intervention: Randomization of study population to ONCE daily scheduled BMP or TWICE daily scheduled BMP.

Risk: Risks to both arms of the study are in clinical equipoise and include: Hypokalemia, hyperkalemia, arrhythmia (secondary to hypokalemia or hyperkalemia), delayed identification of rising creatinine (acute kidney injury).

Project goals: Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University Medical Center. However, it is unclear how often the second BMP each day is acted on. Our project aims to answer a few fundamental questions about the need for twice daily labs in patients hospitalized with acute/subacute-decompensated congestive heart failure who are being actively diuresed.

Descriptive:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Acute decompensated Heart failure (ADHF)
  • actively being diuresed (home dose or greater of diuretics)
  • presentation within 24 hr of enrollment
  • having a history of chronic HF.
  • Exclusion criteria:
  • First time heart failure diagnosis
  • systolic blood pressure < 90mmHg
  • patients requiring inotropes (other than digoxin) or milrinone
  • estimated glomerular filtration rate <10.

排除标准

  • 未提供

研究组 & 干预措施

Once daily BMP

Active Comparator

Patient in this arm will receive once daily basic metabolic panel to monitor electrolytes

干预措施: Basic metabolic panel (Other)

Twice daily BMP

Active Comparator

Patient in this arm will receive twice daily basic metabolic panel to monitor electrolytes

干预措施: Basic metabolic panel (Other)

结局指标

主要结局

Composite time spent in ideal potassium range

时间窗: entire hospital stay, an expected average of 72 hours

Patients average potassium during their stay will be compared to normal range defined at 3.5-5. 0 (mmol/l). , using general estimating equations allowing for comparisons between groups as well as interpersonally, in addition proportion of labs that are within normal values as stated about will also be compared between groups as well as proportion of labs in the ideal range in each group.

次要结局

  • readmission rate(1 month)
  • Cost associated with hospitalization(entire hospital stay, an expected average of 72 hours)
  • length of stay(entire hospital stay, an expected average of 72 hours)

研究者

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

Christopher Brown

Resident Physician

Vanderbilt University

研究点 (2)

Loading locations...

相似试验

Once Versus Twice Daily Electrolyte Monitoring in CHF | 临床试验