Evaluating adrenal insufficiency after surgery in patients with primary aldosteronism

Study on the Incidence of Adrenal Insufficiency After Surgery in Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion

This study is testing how often people with primary aldosteronism develop adrenal insufficiency after having surgery to remove their adrenal glands.

Quick facts

• Study type: Observational
• Enrollment: 521 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06955286 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the incidence of adrenal insufficiency following adrenalectomy in patients diagnosed with primary aldosteronism, both with and without concurrent autonomous cortisol secretion. Participants will undergo a complete ACTH stimulation test the day after their surgery to evaluate their adrenal function. The study will follow these patients for a period of 6 to 12 months post-surgery to monitor any occurrences of adrenal insufficiency. It is a single-center study conducted at the First Affiliated Hospital of Chongqing Medical University.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with primary aldosteronism who have undergone complete adrenalectomy and are able to complete the ACTH stimulation test.

Not a fit: Patients who have undergone partial adrenalectomy or have conditions such as familial hyperaldosteronism or pheochromocytoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the management of adrenal insufficiency in patients with primary aldosteronism, potentially improving postoperative care.

How similar studies have performed: While similar studies have explored adrenal insufficiency in various contexts, this specific focus on primary aldosteronism and postoperative outcomes is relatively novel.

Eligibility criteria

* A confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion;

  ② Completion of unilateral adrenal surgery;

  ③ Voluntary participation and obtaining informed consent. (2) Exclusion criteria
* Patients with typical clinical manifestations of Cushing's syndrome;

  * Patients suspected of having bilateral cortisol over-secretion, such as PBMAH or PPNAD; ③ Patients with severe surgical complications, unstable postoperative condition (not due to cortical insufficiency), and difficulty completing the ACTH stimulation test;

    * History of ACTH allergy;

      * Patients requiring long-term hormone therapy for other diseases (such as autoimmune diseases);

        * Severe liver and kidney dysfunction (ALT ≥ 3 times the upper limit of normal; patients undergoing dialysis or with an estimated glomerular filtration rate \< 30 ml/min/m2); ⑦ History of contralateral adrenal surgery; ⑧ Patients with poor compliance who are unable to complete the study.

Where this trial is running

Chongqing, Chongqing Municipality

• the First Affiliated Hospital of Chongqing Medical University, Chongqing, China — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li Qifu, PhD

Conditions Primary Aldosteronism; Autonomous Cortisol Secretion; Adrenal Insufficiency; ACTH stimulation test