Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-04 @ 7:16 AM
Study NCT ID:
NCT06534268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'patient serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The gender and age of the participants', 'timeFrame': '1 day', 'description': 'age in years and sex (female or male) of patients'}, {'measure': "Participant's weight and height", 'timeFrame': '1 day', 'description': 'BMI(body mess index) in kg/m\\^2= (weight in kg) /(height in m)\\^2'}, {'measure': "Patients' baseline hormone level", 'timeFrame': '1day', 'description': 'serum hormone level'}, {'measure': 'Number of Participants with baseline glucose metabolic levels', 'timeFrame': '1 day', 'description': 'glucose metabolism, lipid metabolism, liver and kidney function, electrolytes, etc'}, {'measure': "Patients' hormone levels at 0 minutes and 120 minutes after preoperative ACTH stimulation test", 'timeFrame': '1day', 'description': 'cortisol and aldosterone levels'}, {'measure': "Patients' hormone levels at 0 minutes and 120 minutes after postoperative ACTH stimulation test", 'timeFrame': '1day', 'description': 'cortisol and aldosterone levels'}, {'measure': 'Number of Participants with baseline lipid metabolic levels', 'timeFrame': '1day', 'description': 'blood lipid levels'}, {'measure': "Patients' baseline glucose metabolic levels", 'timeFrame': '1day', 'description': '0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT'}, {'measure': 'Number of Participants with baseline electrolytes levels', 'timeFrame': '1day', 'description': 'sodium, potassium, chloride, calcium, and phosphorus ion levels'}, {'measure': 'Number of Participants with baseline kidney function levels', 'timeFrame': '1day', 'description': 'Creatinine, blood urea nitrogen (BUN), and uric acid levels'}], 'secondaryOutcomes': [{'measure': 'the changes of hormone levels after surgical management', 'timeFrame': '1day', 'description': 'cortisol and aldosterone serum hormone level'}, {'measure': 'Number of Participants with changes of lipid metabolic levels after surgical management', 'timeFrame': '1day', 'description': 'blood lipid levels'}, {'measure': 'the changes of glucose metabolic levels after surgical management', 'timeFrame': '1day', 'description': '0-minute、30-minute、60-minute 、120-minute and 180-minute blood glucose levels after OGTT'}, {'measure': 'Number of Participants with changes of kidney function levels after surgical management', 'timeFrame': '1 day', 'description': 'Creatinine, blood urea nitrogen (BUN), and uric acid levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Patients using medications that affect adrenal cortical function.\n* Patients with a history of adrenal surgery\n* Pregnant or breastfeeding women\n* Patients with severe underlying diseases (such as liver or kidney failure) that may affect adrenal cortical function'}, 'identificationModule': {'nctId': 'NCT06534268', 'briefTitle': 'Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Study on Postoperative Adrenal Function Assessment in Patients With Primary Aldosteronism', 'orgStudyIdInfo': {'id': 'RJ-PA-NEW-1'}}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}