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Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism

Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06534268
Enrollment
200
Registered
2024-08-02
Start date
2024-08-15
Completion date
2026-07-30
Last updated
2024-08-02

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

Conditions

Primary Aldosteronism

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

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with baseline kidney function levels1dayCreatinine, blood urea nitrogen (BUN), and uric acid levels
Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test1daycortisol and aldosterone levels
Number of Participants with baseline lipid metabolic levels1dayblood lipid levels
Patients' baseline glucose metabolic levels1day0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT
Number of Participants with baseline electrolytes levels1daysodium, potassium, chloride, calcium, and phosphorus ion levels
The gender and age of the participants1 dayage in years and sex (female or male) of patients
Participant's weight and height1 dayBMI(body mess index) in kg/m\^2= (weight in kg) /(height in m)\^2
Patients' baseline hormone level1dayserum hormone level
Number of Participants with baseline glucose metabolic levels1 dayglucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc
Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test1daycortisol and aldosterone levels

Secondary

MeasureTime frameDescription
Number of Participants with changes of lipid metabolic levels after surgical management1dayblood lipid levels
the changes of glucose metabolic levels after surgical management1day0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT
Number of Participants with changes of kidney function levels after surgical management1 dayCreatinine, blood urea nitrogen (BUN), and uric acid levels
the changes of hormone levels after surgical management1daycortisol and aldosterone serum hormone level

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026