NCT06955286招募中不适用
Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion
Qifu Li1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the Incidence of Adrenal Insufficiency After Surgery
研究概览
简要总结
To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS).
详细描述
This study is a prospective, single-center research. Primary aldosteronism patients concurrent with or without autonomous cortisol secretion who underwent adrenalectomy and completed the adrenocorticotropic hormone (ACTH) stimulation test will be included. To evaluate the incidence of adrenal insufficiency after surgery in these patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PA conccurent with or without autonomous cortisol secretion
- •complete adrenalectomy
- •complete ACTH stimulation test on the one day after surgery
- •complete follow-up at 6，12 months after surgery
排除标准
- •Patients underwent partial adrenalectomy
- •Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history]
- •Suspicion of pheochromocytoma or adrenal carcinoma.
- •Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m2) or Underweight (BMI≤18 kg/m2); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
- •Patients with actively malignant tumor.
- •Long- term use of glucocorticoids.
- •Suspected PBMAH or PPNAD;
结局指标
主要结局
the Incidence of Adrenal Insufficiency After Surgery
时间窗: the one day after surgery
the Incidence of Adrenal Insufficiency After Surgery on the one day after surgery
次要结局
未报告次要终点
研究者
Qifu Li
Primary investigator
Chongqing Medical University
研究点 (1)
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