Decline in Renal Concentration Ability in Lithium Treated Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Decline renal concentration ability
研究概览
简要总结
Lithium therapy is cornerstone in therapy of bipolar disorders. A well known side-effect of lithium therapy is a urinary concentration defect which manifests in it's most severe form as nephrogenic diabetes insipidus. The development of urinary concentration defects and its progression to nephrogenic diabetes insipidus in the population of lithium treated patients is unknown and therefore this study aims to evaluate the decline of urinary concentration defects in a Dutch population of lithium treated patients. In this prospective cohort study, 51 participants treated with lithium at Canisius Wilhelmina Hospital, Nijmegen and included in the previous study in 2012 will be approached to undergo a follow-up dDAVP-test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •included in the previous study
- •men and women
- •age ≥ 18 years
排除标准
- •General contra-indications for participation in a trial:
- •inability to give informed consent
- •pregnancy
- •unstable psychiatric condition
- •Alternative causes of (nephrogenic) diabetes insipidus:
- •hypokalemia (plasma potassium < 3.0 mmol/l)
- •severe hypercalcemia (albumin-corrected plasma calcium > 2.80 mmol/l)
- •hyperglycemia (plasma glucose > 10.0 mmol/l)
- •history of amyloidosis, Sjögren's syndrome or Sickle cell anemia
- •previous treatment with ifosfamide
- •established primary polydipsia or central diabetes insipidus
- •Contra-indications for dDAVP administration:
- •inability to comply with water restriction
- •renal insufficiency (GFR < 45 ml/min/1.73 m2)
- •hyponatremia (plasma sodium < 130 mmol/l)
- •instable angina pectoris
- •decompensated cardial insufficiency
- •concomitant treatment with desmopressin or democlocycline
结局指标
主要结局
Decline renal concentration ability
时间窗: 10 years
To explore the decline in renal concentration ability (RCA) in a Dutch population of lithium treated patient. The primary endpoint is the percentual change in maximal urine osmolality.
次要结局
- Chronic kidney disease(10 years)
- Relation between changes in kidney function and renal concentration ability(10 years)
- Decline in kidney-function(10 years)
- Relation between history of lithium-use and renal concentration ability(10 years)