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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Primary Aldosteronism | primary aldosteronism patients underwent surgical treatment and completed the ACTH stimulation test |
| |
| Patients With Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion | primary aldosteronism patients concurrent with autonomous cortisol secretion underwent surgical treatment and completed the ACTH stimulation test |
| |
| Patients With With Autonomous Cortisol Secretion | patients with autonomous cortisol secretion underwent surgical treatment and completed the ACTH stimulation test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | the one day after surgery |
| 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 | the one day after surgery, or 1 and 4 weeks after surgery, or 3 or 6 months after surgery |
| 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 | 3 or 6 months after surgery |
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A confirmed diagnosis of primary aldosteronism or autonomous cortisol secretion;
â‘¡ Completion of unilateral adrenal surgery;
â‘¢ 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; â‘¢ 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);
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Primary Aldosteronism Patients Concurrent With or Without Autonomous Cortisol Secretion who underwent surgery and completed the ACTH stimulation test
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Qifu, PhD | Contact | +86-023-89011552 | liqifu@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Chongqing Medical University, Chongqing, China | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218017 | Result | Libianto R, Russell GM, Stowasser M, Gwini SM, Nuttall P, Shen J, Young MJ, Fuller PJ, Yang J. Detecting primary aldosteronism in Australian primary care: a prospective study. Med J Aust. 2022 May 2;216(8):408-412. doi: 10.5694/mja2.51438. Epub 2022 Feb 25. | |
| 32327102 | Result | Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052. |
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plasma
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| 21593113 | Result | Nakajima Y, Yamada M, Taguchi R, Satoh T, Hashimoto K, Ozawa A, Shibusawa N, Okada S, Monden T, Mori M. Cardiovascular complications of patients with aldosteronism associated with autonomous cortisol secretion. J Clin Endocrinol Metab. 2011 Aug;96(8):2512-8. doi: 10.1210/jc.2010-2743. Epub 2011 May 18. |
| 35418526 | Result | Naruse M, Katabami T, Shibata H, Sone M, Takahashi K, Tanabe A, Izawa S, Ichijo T, Otsuki M, Omura M, Ogawa Y, Oki Y, Kurihara I, Kobayashi H, Sakamoto R, Satoh F, Takeda Y, Tanaka T, Tamura K, Tsuiki M, Hashimoto S, Hasegawa T, Yoshimoto T, Yoneda T, Yamamoto K, Rakugi H, Wada N, Saiki A, Ohno Y, Haze T. Japan Endocrine Society clinical practice guideline for the diagnosis and management of primary aldosteronism 2021. Endocr J. 2022 Apr 28;69(4):327-359. doi: 10.1507/endocrj.EJ21-0508. Epub 2022 Apr 12. |
| 37410097 | Result | Araujo-Castro M, Paja Fano M, Pla Peris B, Gonzalez Boillos M, Pascual-Corrales E, Garcia-Cano AM, Parra Ramirez P, Rojas-Marcos PM, Ruiz-Sanchez JG, Vicente A, Gomez-Hoyos E, Ferreira R, Garcia Sanz I, Recasens M, Barahona San Millan R, Picon Cesar MJ, Diaz Guardiola P, Perdomo C, Manjon L, Garcia-Centeno R, Percovich JC, Rebollo Roman A, Gracia Gimeno P, Robles Lazaro C, Morales M, Calatayud M, Collao SAF, Meneses D, Sampedro Nunez MA, Escudero Quesada V, Ribas EM, Sanmartin Sanchez A, Diaz CG, Lamas C, Guerrero-Vazquez R, Del Castillo Tous M, Serrano J, Michalopoulou T, Moya Mateo EM, Hanzu F. Autonomous cortisol secretion in patients with primary aldosteronism: prevalence and implications on cardiometabolic profile and on surgical outcomes. Endocr Connect. 2023 Aug 2;12(9):e230043. doi: 10.1530/EC-23-0043. |
| 23385627 | Result | Fujimoto K, Honjo S, Tatsuoka H, Hamamoto Y, Kawasaki Y, Matsuoka A, Ikeda H, Wada Y, Sasano H, Koshiyama H. Primary aldosteronism associated with subclinical Cushing syndrome. J Endocrinol Invest. 2013 Sep;36(8):564-7. doi: 10.3275/8818. Epub 2013 Feb 4. |
| 35380982 | Result | Katabami T, Matsuba R, Kobayashi H, Nakagawa T, Kurihara I, Ichijo T, Tsuiki M, Wada N, Ogawa Y, Sone M, Inagaki N, Yoshimoto T, Takahashi K, Yamamoto K, Izawa S, Kakutani M, Tanabe A, Naruse M. Primary aldosteronism with mild autonomous cortisol secretion increases renal complication risk. Eur J Endocrinol. 2022 Apr 25;186(6):645-655. doi: 10.1530/EJE-21-1131. |
| 35900323 | Result | Wu WC, Peng KY, Lu JY, Chan CK, Wang CY, Tseng FY, Yang WS, Lin YH, Lin PC, Chen TC, Huang KH, Chueh JS, Wu VC. Cortisol-producing adenoma-related somatic mutations in unilateral primary aldosteronism with concurrent autonomous cortisol secretion: their prevalence and clinical characteristics. Eur J Endocrinol. 2022 Sep 14;187(4):519-530. doi: 10.1530/EJE-22-0286. Print 2022 Oct 1. |
| 38561283 | Result | Liao YY, Song Y, Hu JB, Yang SM, Zheng Y, Li QF. [Clinical characteristics and prognosis of primary aldosteronism associated with subclinical Cushing syndrome]. Zhonghua Nei Ke Za Zhi. 2024 Apr 1;63(4):378-385. doi: 10.3760/cma.j.cn112138-20230830-00100. Chinese. |
| 34558612 | Result | DeLozier OM, Dream SY, Findling JW, Carroll TB, Evans DB, Wang TS. Selective Glucocorticoid Replacement Following Unilateral Adrenalectomy for Hypercortisolism and Primary Aldosteronism. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e538-e547. doi: 10.1210/clinem/dgab698. |
| 30865224 | Result | Gerards J, Heinrich DA, Adolf C, Meisinger C, Rathmann W, Sturm L, Nirschl N, Bidlingmaier M, Beuschlein F, Thorand B, Peters A, Reincke M, Roden M, Quinkler M. Impaired Glucose Metabolism in Primary Aldosteronism Is Associated With Cortisol Cosecretion. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3192-3202. doi: 10.1210/jc.2019-00299. |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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