Clinical trial NCT06534268: Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
Official title: Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Aldosteronism
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study intends to include 200 patients diagnosed with primary aldosteronism undergoing surgery. An ACTH stimulation test will be performed within one week postoperatively. The participants will be aged 18-75 years, with no gender restrictions. Exclusion criteria include patients using medications that affect adrenal cortical function, patients with a history of adrenal surgery, pregnant or breastfeeding women, and patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function

Brief summary: This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

Detailed description: Patients suspected of having primary aldosteronism and admitted for treatment, who are diagnosed with primary aldosteronism through at least one confirmatory test, and subsequently diagnosed with unilateral primary aldosteronism via bilateral adrenal vein sampling and ACTH stimulation test, will undergo surgery. Those who have an ACTH stimulation test within one week postoperatively will be included in the study.

This study employs a prospective, single-center, open, observational research design to evaluate postoperative adrenal cortical function in patients with primary aldosteronism (PA) and to explore indicators predicting postoperative adrenal insufficiency and their predictive efficacy

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with unilateral primary aldosteronism who undergo surgical treatment and have their cortical function assessed by an ACTH stimulation test within one week postoperatively.

Exclusion Criteria:

* Patients using medications that affect adrenal cortical function.
* Patients with a history of adrenal surgery
* Pregnant or breastfeeding women
* Patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function

Primary outcomes:
measure: The gender and age of the participants
timeFrame: 1 day
measure: Participant's weight and height
timeFrame: 1 day
measure: Patients' baseline hormone level
timeFrame: 1day
measure: Number of Participants with baseline glucose metabolic levels
timeFrame: 1 day
measure: Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test
timeFrame: 1day
measure: Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test
timeFrame: 1day
measure: Number of Participants with baseline lipid metabolic levels
timeFrame: 1day
measure: Patients' baseline glucose metabolic levels
timeFrame: 1day
measure: Number of Participants with baseline electrolytes levels
timeFrame: 1day
measure: Number of Participants with baseline kidney function levels
timeFrame: 1day
Secondary outcomes:
measure: the changes of hormone levels after surgical management
timeFrame: 1day
measure: Number of Participants with changes of lipid metabolic levels after surgical management
timeFrame: 1day
measure: the changes of glucose metabolic levels after surgical management
timeFrame: 1day
measure: Number of Participants with changes of kidney function levels after surgical management
timeFrame: 1 day
Other outcomes:
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