Appropriate Limit Value for 1 mg DST in Patients With Chronic Renal Failure

NCT05568602 | Completed

• 1 other identifier: OzlemUstay3
• Study Type: observational
• Target: 1,034
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aimed to determine a specific cut-off value for 1mg DST to prevent false positivity usually seen in CRF patients according to the standard cut-off value of 1.8 mcg/dl.

Conditions

Cushing Syndrome

Keywords

cushing, dexamethasone suppression test, chronic renal failure

Outcome Measures

Primary Outcomes (1)

• cut-off value for DST

  to determine specific cut point for 1mg DST in chronic renal failure

  1 year

Study Arms (2)

GFR<30 ml/min

Patients screened for hypercortisolism and GFR\<30ml/min

Diagnostic Test: Dexamethasone suppression test

GFR>30 ml/min

Patients screened for hypercortisolism and GFR\>30ml/min

Diagnostic Test: Dexamethasone suppression test

Interventions

Dexamethasone suppression test DIAGNOSTIC_TEST

1 mg Dexamethasone overnight suppression test for screening of hypercortisolism

GFR<30 ml/min; GFR>30 ml/min

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between 01 January 2018 and 31 December 2019, 2173 patients who were admitted to the outpatient clinic of our hospital's Endocrine and Metabolic Diseases Department and requested 1 mg DST were included in the screening.

You may qualify if:

• Between 01 January 2018 and 31 December 2019, 2173 patients who were admitted to the outpatient clinic of our hospital's Endocrine and Metabolic Diseases Department and requested 1 mg DST were included in the screening.

You may not qualify if:

• Being under 18 years of age
• Liver cirrhosis and /or 3-fold or more increase in liver enzymes
• Use of drugs known to interact with dexamethasone (psychotropic agents, oral contraceptives, anti-epileptic drugs, barbiturates, etc.)
• An adrenal nodule or pituitary adenoma is detected, but it is at the stage of evaluation whether it is functional or not
• Typical CS clinical findings (such as Purple stria, Buffalo Hump, moon face)
• Having an adrenal nodule or pituitary adenoma and being followed by an external center
• Lack of access to be analyzed information in the study: Albumin, AST, ALT, creatine, white blood cell (WBC), C-Reactive Protein (CRP), glycosylated hemoglobin percentage (HBA1c), glucose, sodium, potassium, thyroid stimulating hormone (TSH), body mass index (BMI), known disease and drug use information, lipid profile tests and information, lack of access to the patient's previous data
• Having a diagnosis of severe major depression
• Previously diagnosed with Cushing Syndrome or operated with this diagnosis
• Prominent hypoalbuminemia (albumin \<3 g / dl)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Özlem ÜSTAY

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cushing Syndrome; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Özlem ÜSTAY

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 5, 2022
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)