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Clinical Trials in China / NCT06955286
Recruiting Observational

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

NCT06955286 · tracked via the Priya Life Science China tracker
Sponsor
Qifu Li
Phase
Observational
Started
2025-01-02
Last updated
2026-05-01

Condition(s) studied

Primary AldosteronismAutonomous Cortisol SecretionAdrenal Insufficiency

Investigational drug(s) / intervention(s)

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
* 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.

Primary outcome measure(s)

  • the Incidence rate of Adrenal Insufficiency After Surgery — 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
  • the recovery time of postoperative Adrenal Insufficiency in patients — 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
  • the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy — 3 or 6 months after surgery
    the clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

Trial sites (1)

FacilityCityRegionStatus
the First Affiliated Hospital of Chongqing Medical University, Chongqing, China Chongqing Chongqing Municipality Recruiting

More Qifu Li trials in China

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT) Recruiting
Accuracy of 68Ga-Pentixafor PET/CT for Subtypting Diagnosis in Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion Recruiting
Steroids-Based Screening for Primary Aldosteronism Recruiting
Environment, Inflammation and Metabolic Diseases Study Recruiting

Other trials for the same condition

Multi-omics Studies of Primary Aldosteronism Recruiting
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT) Recruiting
The Effect of SAAE on Ventricular Remodeling in PA Patients Recruiting
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol Recruiting
Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06955286 on ClinicalTrials.gov ↗ ← All trials in China