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

ConditionsPrimary AldosteronismAutonomous Cortisol SecretionAdrenal Insufficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorQifu Li

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

A confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion;

Disqualifiers

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);

Trial population

Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion who underwent surgery and completed the ACTH stimulation test

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

521 Participants
are divided into 3 treatment groups
Group A: Patients With Primary Aldosteronism1 intervention
Group B: Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion1 intervention
Group C: Patients With With Autonomous Cortisol Secretion1 intervention

Trial outcomes

Primary outcomes

1

the Incidence rate of Adrenal Insufficiency 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

Time frame
the one day after surgery
2

the recovery time of postoperative Adrenal Insufficiency in patients

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

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

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

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

Time frame
3 or 6 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qifu Li

Lead sponsor

Chongqing Medical University

Sponsor institution

Source ClinicalTrials.gov
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