Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism

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 Overview

• Status: Not yet recruiting
• Conditions: Primary Aldosteronism

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

• Study Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The gender and age of the participants	age in years and sex (female or male) of patients	1 day
Participant's weight and height	BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2	1 day
Patients' baseline hormone level	serum hormone level	1day
Number of Participants with baseline glucose metabolic levels	glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc	1 day
Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test	cortisol and aldosterone levels	1day
Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test	cortisol and aldosterone levels	1day
Number of Participants with baseline lipid metabolic levels	blood lipid levels	1day
Patients' baseline glucose metabolic levels	0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT	1day
Number of Participants with baseline electrolytes levels	sodium, potassium, chloride, calcium, and phosphorus ion levels	1day
Number of Participants with baseline kidney function levels	Creatinine, blood urea nitrogen (BUN), and uric acid levels	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of hormone levels after surgical management	cortisol and aldosterone serum hormone level	1day
Number of Participants with changes of lipid metabolic levels after surgical management	blood lipid levels	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	1day
Number of Participants with changes of kidney function levels after surgical management	Creatinine, blood urea nitrogen (BUN), and uric acid levels	1 day

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: RJ-PA-NEW-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No