Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism

N/ANot Yet RecruitingNCT06534268

Ruijin Hospital200 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Primary Aldosteronism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The gender and age of the participants

age in years and sex (female or male) of patients

Time frame: 1 day

Participant's weight and height

BMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2

Time frame: 1 day

Patients' baseline hormone level

serum hormone level

Time frame: 1day

Number of Participants with baseline glucose metabolic levels

glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc

Time frame: 1 day

Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test

cortisol and aldosterone levels

Time frame: 1day

Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test

cortisol and aldosterone levels

Time frame: 1day

Number of Participants with baseline lipid metabolic levels

blood lipid levels

Time frame: 1day

Patients' baseline glucose metabolic levels

0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT

Time frame: 1day

Number of Participants with baseline electrolytes levels

sodium, potassium, chloride, calcium, and phosphorus ion levels

Data from ClinicalTrials.gov

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Secondary Outcomes

the changes of hormone levels after surgical management

cortisol and aldosterone serum hormone level

Time frame: 1day

Number of Participants with changes of lipid metabolic levels after surgical management

blood lipid levels

Time frame: 1day

the changes of glucose metabolic levels after surgical management

0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT

Time frame: 1day

Number of Participants with changes of kidney function levels after surgical management

Creatinine, blood urea nitrogen (BUN), and uric acid levels

Time frame: 1 day