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NCT Number: NCT06955286

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

To evaluate the incidence of adrenal insufficiency after surgery in Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS). To assess the recovery time of postoperative adrenal insufficiency in patients. And to explore the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy.

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Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenal Insufficiency Adrenocortical Hyperfunction Autonomous Cortisol Secretion Endocrine System Diseases Hyperaldosteronism

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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 Primary aldosteronism (PA) patients concurrent with or without autonomous cortisol secretion (ACS). To assess the recovery time of postoperative adrenal insufficiency in patients. And to explore the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

complete ACTH stimulation test the day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Diagnostic Test

patients complete ACTH stimulation test on the one day after surgery and complete ACTH stimulation test 1 or 4 week for patients with Adrenal Insufficiency

Primary outcomes

  1. the Incidence rate of Adrenal Insufficiency After Surgery

    Time frame: the one day after surgery

    the Incidence rate of Adrenal Insufficiency After Surgery on the one day after surgery，which is defined as serum cortisol ≤ 390nmol/l 60 minutes after ACTH continuous infusion

  2. the recovery time of postoperative Adrenal Insufficiency in patients

    Time frame: the one day after surgery, or 1 and 4 weeks after surgery, or 3 or 6 months after surgery

    the recovery time of postoperative Adrenal Insufficiency in patients. The patients will be completed ACTH stimulation test at 1 and 4 weeks after surgery. If serum cortisol > 390nmol/l 60 minutes after ACTH continuous infusion，the patients will be considered as recovery

  3. the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

    Time frame: 3 or 6 months after surgery

    the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Li Qifu, PhD

CONTACT

[email protected]

+86-023-89011552

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 2, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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