Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604975
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPEPCHILD
Brief Summary:
The exploration of polyuro-polydipsia syndrome PPS with hypotonic polyuria should distinguished primary polydipsia PP due to excessive water intake central diabetes insipidus CDI related to insufficient secretion of antidiuretic hormone AVP and nephrogenic diabetes insipidus NDI related to AVP insensitivity The determination of plasma AVP is not relevant unstable concentration short in vitro half-life long technical time and large blood sample The differential diagnosis is currently based on a water deprivation test WDT an indirect reflection of AVP action requiring more than 6 hours of hospitalization with risk of dehydration and low accuracy Copeptin represents a new biomarker direct mirror of AVP release with remarkable characteristics stable rapid determination small blood volume Copeptin has become a diagnostic tool in adult PPS and eliminated WDT in the diagnostic process In children basal copeptin values help for NDI and to exclude CDI basal copeptin threshold 30 and 353 pmoll Se 100 Sp 874 respectively Below 353 pmoll basal copeptin performance was inadequate to discriminate PP and CDI highlighting the relevance of the stimulated copeptin study to improve this strategy The arginine stimulation test is widely used as a simple short duration 2 hours and well tolerated tool to diagnose growth hormone deficiency in pediatrics The performance of this test for copeptin stimulation was studied in adults with PPS with a high diagnostic accuracy
The aim of the study is identify the best discriminant threshold of the arginine stimulation test in the uncertain diagnosis basal copeptin 30 pmoll in the polyuro-polydipsic syndrome in children
Then evaluate the discriminative capacities of the arginine stimulation test between the primary polydipsia and central insipid diabetes in the polyuro-polydipsic syndrome in children And finally evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children and evaluate the impact of infusion volume on copeptin secretion using the protidemia copeptin ratio
The aim of the study is identify the best discriminant threshold of the arginine stimulation test in the uncertain diagnosis basal copeptin 30 pmoll in the polyuro-polydipsic syndrome in children
Then evaluate the discriminative capacities of the arginine stimulation test between the primary polydipsia and central insipid diabetes in the polyuro-polydipsic syndrome in children And finally evaluate the cost-effectiveness of a new decisional algorithm for the differential diagnosis of PPS in children and evaluate the impact of infusion volume on copeptin secretion using the protidemia copeptin ratio
Detailed Description:
Routine biochemical tests are performed to screen patients for PPS and determine basal copeptin level after solid fasting since midnight without water restriction 1 a basal copeptin value 30 pmolL defines the diagnosis of NDI and results in a specific care 2 a basal copeptin 30 pmolL defines the group of eligible patients for arginine stimulation The arginine-stimulated copeptin test start at 8 am at the dose of 05 gkg over 30min Copeptin is measured at T0 before infusion T45 T60 T90 and T120 min after infusion
Patients with basal copeptin value over 353 pmolL are considered as positive diagnosis of PP Se 100 Sp 874 and cerebral MRI is not performed for this group of patients PP group
Patients with basal copeptin value 353 pmolL are considered as an uncertain diagnosis UD and cerebral and pituitary MRI is performed with a least two independent interpretations Abnormal pituitary MRI allows a diagnosis of CDI leading to etiological investigations and AVP treatment Patients with basal copeptin 353 pmoll PP group and UD patients with normal MRI have gradual reduction of water intake without AVP treatment For all these latest patients a clinical and biological reevaluation is performed one month later
The gold standard will be the final diagnosis PP vs CDI based on a set of indicators medical history physical examination pituitary hormonal assessment hypothalamo-pituitary MRI follow-up at 1 month
Patients with basal copeptin value over 353 pmolL are considered as positive diagnosis of PP Se 100 Sp 874 and cerebral MRI is not performed for this group of patients PP group
Patients with basal copeptin value 353 pmolL are considered as an uncertain diagnosis UD and cerebral and pituitary MRI is performed with a least two independent interpretations Abnormal pituitary MRI allows a diagnosis of CDI leading to etiological investigations and AVP treatment Patients with basal copeptin 353 pmoll PP group and UD patients with normal MRI have gradual reduction of water intake without AVP treatment For all these latest patients a clinical and biological reevaluation is performed one month later
The gold standard will be the final diagnosis PP vs CDI based on a set of indicators medical history physical examination pituitary hormonal assessment hypothalamo-pituitary MRI follow-up at 1 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None