Diagnosing adrenal insufficiency in patients with liver cirrhosis
Investigation of Incidence and Proper Diagnostic Method for Adrenal Insufficiency in Liver Cirrhosis Patients
Seoul National University Hospital · NCT06206655
This study is testing different ways to diagnose adrenal insufficiency in patients with liver cirrhosis to see which method is the most accurate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06206655 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of adrenal insufficiency (AI) in patients suffering from liver cirrhosis (LC). It will recruit 50 patients with LC who will undergo a rapid ACTH stimulation test, with blood and saliva samples collected for analysis. The study will investigate the differences between serum free cortisol, total cortisol, and salivary cortisol to determine the most accurate method for diagnosing AI in this patient population. The approach focuses on addressing the controversy surrounding the over-diagnosis of AI in LC patients due to altered cortisol levels.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with liver cirrhosis.
Not a fit: Patients who are pregnant, have undergone pituitary or adrenal surgery, or have acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of adrenal insufficiency in liver cirrhosis patients, improving their management and treatment.
How similar studies have performed: While there is ongoing debate regarding the diagnosis of adrenal insufficiency in liver cirrhosis, this specific approach using salivary cortisol and mass-spectrometry has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients diagnosed of liver cirrhosis Exclusion Criteria: * pregnant * history of getting surgery of pituitary resection or adrenalectomy * patients with diagnosis of pituitary adenoma or adrenal adenoma * patients take steroid within 3 months * patients take medication related to synthesis of steroid or cortisol binding protein within 3 months (i.e. ketoconazole, etomidate, sex hormone, oral contraceptive) * patients take albumin, free frozen plasma, terlipressin, glypressin within 1 month * patients with acute medical condition
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Junghee Kim, M.D., Ph.D. — Seoul National University Hospital
- Study coordinator: Min Jeong Park
- Email: minjeong87@gmail.com
- Phone: 01072713805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adrenal Insufficiency, Liver Cirrhosis