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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06955286
Enrollment
521
Registered
2025-05-02
Start date
2025-01-02
Completion date
2028-12-31
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency, Autonomous Cortisol Secretion, Primary Aldosteronism

Keywords

Primary Aldosteronism, Autonomous Cortisol Secretion, Adrenal Insufficiency, ACTH stimulation test

Brief 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.

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 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..

Interventions

DIAGNOSTIC_TESTcomplete 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

Sponsors

Qifu Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
the Incidence rate of Adrenal Insufficiency After Surgerythe one day after surgerythe 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 patientsthe one day after surgery, or 1 and 4 weeks after surgery, or 3 or 6 months after surgerythe 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 therapy3 or 6 months after surgerythe clinical characteristics and predictive indicators of patients requiring postoperative hormone replacement therapy

Countries

China

Contacts

CONTACTLi Qifu, PhD
liqifu@yeah.net+86-023-89011552

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026