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NCT Number: NCT06534268

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The gender and age of the participants

    Time frame: 1 day

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

  2. Participant's weight and height

    Time frame: 1 day

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

  3. Patients' baseline hormone level

    Time frame: 1day

    serum hormone level

  4. Number of Participants with baseline glucose metabolic levels

    Time frame: 1 day

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

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

    Time frame: 1day

    cortisol and aldosterone levels

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

    Time frame: 1day

    cortisol and aldosterone levels

  7. Number of Participants with baseline lipid metabolic levels

    Time frame: 1day

    blood lipid levels

  8. Patients' baseline glucose metabolic levels

    Time frame: 1day

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

  9. Number of Participants with baseline electrolytes levels

    Time frame: 1day

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

  10. Number of Participants with baseline kidney function levels

    Time frame: 1day

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

Secondary outcomes

  1. the changes of hormone levels after surgical management

    Time frame: 1day

    cortisol and aldosterone serum hormone level

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

    Time frame: 1day

    blood lipid levels

  3. the changes of glucose metabolic levels after surgical management

    Time frame: 1day

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

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

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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