Diagnosing Natriuretic Peptide Deficiency: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in NT-proANP From Baseline to 8 Hours
研究概览
简要总结
In this pilot study, the investigators will determine the response of the natriuretic peptide (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The goal of the proposed project is to generate preliminary data that will be used to develop power calculations, inform cutoff ranges, and inform the timing of the NP response for larger subsequent studies.
Aim: To determine the range of distribution and time course of natriuretic peptide (NP) responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.
Hypothesis: Determination of the NP responses (the range and time course of changes in NP levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency of blood sampling in a definitive prospective study, as well as enable investigators to perform a sample size calculation for a definitive prospective study.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Significant use of systemically-absorbed glucocorticoids currently or for an extended period of time during the prior 6 months
- •Current use of antihypertensive medications
- •Current use of metformin, or any antidiabetic medications (which could affect glucose and insulin levels)
- •Current use of medications known to affect dexamethasone metabolism, including phenytoin, rifampin, carbamazepine, troglitazone, and barbiturates
- •Active, clinically significant infection at time of visit
- •History of adrenal insufficiency or Cushing's syndrome
- •Prior or current cardiovascular disease, renal disease, or liver disease
- •Diabetes mellitus, pre-diabetes, impaired fasting glucose, or impaired glucose tolerance
- •Atrial fibrillation
- •Bleeding disorder or anemia
- •Elevated Liver Functions Tests > 2 times upper limit of normal
- •Estimated glomerular filtration rate < 60 ml/min
- •HbA1c > 5.7
- •Abnormal sodium or potassium level
- •Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
研究组 & 干预措施
Healthy
10 Healthy subjects will undergo study procedures at four study visits.
All subjects will undergo the same procedures and interventions.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Changes in NT-proANP From Baseline to 8 Hours
时间窗: baseline and 8 hours
Change in natriuretic peptide levels after drug administration
Changes in NT-proBNP From Baseline to 8 Hours
时间窗: Baseline and 8 hours
Change in natriuretic peptide levels after drug administration
次要结局
- Changes in NT-proANP(baseline, 24 hours, 48 hours and 72 hours)
- Changes in NT-proBNP(at baseline, 24 hours, 48 hours and 72 hours)
- BNP (B-type Natriuretic Peptide)(0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration)
- ANP (Atrial Natriuretic Peptide)(0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration)
研究者
Katherine N. Bachmann, MD
Instructor in Medicine
Vanderbilt University Medical Center