Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05568602
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2022-10-02
Brief Title:
Appropriate Limit Value for 1 mg DST in Patients With Chronic Renal Failure
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Determination of Appropriate Limit Value for Low Dose Dexamethasone Suppression Test in Patients With Chronic Renal Failure
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 18 mcgdl
Detailed Description:
Chronic renal failure CRF can cause false positivity of overnight 1 mg dexamethasone suppression test 1 mg DST in whom suspicious for Cushing Syndrome due to variability in dexamethasone bioavailability increased cortisol secretion disruption of diurnal rhythm imbalance in free and bound cortisol levels because of decreased protein levels in CRF patients 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 18 mcgdl
The data of 1038 patients who applied to Marmara University endocrinology outpatient clinic between January 01 2018 and December 31 2019 and who were asked for 1 mg DST were retrospectively scanned from the hospital information and management system The patients were divided into 4 groups according to their glomerular filtration rates GFR 1 mg DST results were evaluated according to GFR and ROC analysis was applied to determine the new limit value for the group whose GFR 30 mlmin 173m2 In patients classified as Group IV the patients GFR below 30 mlmin 173m2 both 1 mg DST median and Pseudocushing Syndrome incidence were significantly higher than in other groups The new cut-off value was found to be 32 mcgdl with 100 Sensitivity and 92 specificity
This is the first study determining a specific limit value for 1 mg DST in CRF patients with GFR below 30 mlmin 173m2 to avoid false positivity in these patients Further studies are needed in more patients on hemodialysis to check the clinically more accurate 1 mg DST cutoff value in this specific population
The data of 1038 patients who applied to Marmara University endocrinology outpatient clinic between January 01 2018 and December 31 2019 and who were asked for 1 mg DST were retrospectively scanned from the hospital information and management system The patients were divided into 4 groups according to their glomerular filtration rates GFR 1 mg DST results were evaluated according to GFR and ROC analysis was applied to determine the new limit value for the group whose GFR 30 mlmin 173m2 In patients classified as Group IV the patients GFR below 30 mlmin 173m2 both 1 mg DST median and Pseudocushing Syndrome incidence were significantly higher than in other groups The new cut-off value was found to be 32 mcgdl with 100 Sensitivity and 92 specificity
This is the first study determining a specific limit value for 1 mg DST in CRF patients with GFR below 30 mlmin 173m2 to avoid false positivity in these patients Further studies are needed in more patients on hemodialysis to check the clinically more accurate 1 mg DST cutoff value in this specific population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None