Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Range of Variation in Copeptin
研究概览
简要总结
Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP.
Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing.
Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age.
This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •Age 18-30 years or ≥ 60 years
- •Normonatremia (135-145 mmol/L)
- •Plasma osmolality 280-300 mOsm/kg
- •BMI ≥18 and ≤ 30 kg/m2
排除标准
- •Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.)
- •Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy
- •Pacemaker or ICD
- •History of thrombosis
- •Active oncologic disease
- •Heart failure
- •Liver cirrhosis
- •Estimated glomerular filtration rate (eGFR) < 60 ml/kg/1.73 m2
- •Uncontrolled hypertension >160 mmHg systolic or >100 mmHg diastolic
- •Polydipsia (ingestion of >3L fluids per day) and polyuria (>50 ml/kg urine production within 24 hours)
- •Pregnancy or breastfeeding
- •Participation in a study with investigational drugs within 30 days
- •Acute illness
- •Inability to follow study procedures
研究组 & 干预措施
Stimulation first, Suppression second
干预措施: Hypertonic 3% saline (Other)
Suppression first, Stimulation second
干预措施: Hypertonic 3% saline (Other)
Stimulation first, Suppression second
干预措施: Water (Other)
Suppression first, Stimulation second
干预措施: Water (Other)
结局指标
主要结局
Range of Variation in Copeptin
时间窗: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
The primary outcome is the range of variation in copeptin, i.e. difference of suppressed copeptin to the stimulated copeptin, in healthy elderly participants compared to young controls.
次要结局
- Changes in plasma sodium (mmol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma potassium (mmol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma chloride (mmol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma osmolality (mOsm/kg)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in estimated glomerular filtration rate (ml/kg/1.73m2)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma glucose (mmol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma urea (mmol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in plasma uric acid (umol/L)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine osmolality (mOsm/kg)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine sodium (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine potassium (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine chloride (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine urea (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine uric acid (umol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine glucose (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in urine creatinine (umol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in Copeptin upon stimulation and suppression(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Differences in total body water (L) measured by body impedance analysis(at Baseline)
- Changes in cortisol (mmol/L)(Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in blood pressure (mmHg)(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)
- Changes in heart rate(Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion)