Clinical trial NCT06955286: Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion
Official title: Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Aldosteronism
Autonomous Cortisol Secretion
Adrenal Insufficiency
Keywords: Primary Aldosteronism
Autonomous Cortisol Secretion
Adrenal Insufficiency
ACTH stimulation test
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion who underwent surgery and completed the ACTH stimulation test

Brief summary: To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism patients concurrent with or without autonomous cortisol secretion.

Detailed description: This study is a prospective, single-center research. Primary aldosteronism patients concurrent with or without autonomous cortisol secretion who underwent adrenalectomy and completed the ACTH stimulation test will be included. To evaluate the incidence of adrenal insufficiency after surgery in these patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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;

Primary outcomes:
measure: the Incidence of Adrenal Insufficiency After Surgery
timeFrame: the one day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
state: Chongqing
Study officials:
References:
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