Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04326569
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2020-03-26
Brief Title:
Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
Not yet recruiting
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:
Copeptin-surg
Brief Summary:
Endoscopic trans-sphenoidal pituitary endoscopic surgery is one of the main axes of management of tumours of the sellar region
Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery with a prevalence of up to 30 of cases It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin AVP by the posterior pituitary Melmed et al 2017
In the absence of specific treatment diabetes insipidus can lead to severe ionic and osmotic disorders mainly acute dehydration with the risk of severe consequences particularly neurological
Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period
To date diabetes insipidus is initially suspected before the appearance of major polyuria Several biological assays urinary density natraemia urinary osmolarity and plasma can help to confirm the diagnosis but the sensitivity and specificity of these biomarkers remains quite low for this indication
The determination of MVA is difficult because this hormone is unstable ex vivo To date its use in current practice remains complicated
MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions
Copeptin has a relatively short in vivo half-life of about 25 minutes as does MVA but is more stable in vitro when blood has been drawn
Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest
Central diabetes insipidus is a frequent complication of endoscopic trans-sphenoidal pituitary endoscopic surgery with a prevalence of up to 30 of cases It is the consequence of insufficient secretion of the anti-diuretic hormone arginine vasopressin AVP by the posterior pituitary Melmed et al 2017
In the absence of specific treatment diabetes insipidus can lead to severe ionic and osmotic disorders mainly acute dehydration with the risk of severe consequences particularly neurological
Monitoring for the appearance of diabetes insipidus is therefore necessary from the immediate post-operative period
To date diabetes insipidus is initially suspected before the appearance of major polyuria Several biological assays urinary density natraemia urinary osmolarity and plasma can help to confirm the diagnosis but the sensitivity and specificity of these biomarkers remains quite low for this indication
The determination of MVA is difficult because this hormone is unstable ex vivo To date its use in current practice remains complicated
MVA and copeptin are derived from the same precursor and are therefore co-secreted by the pituitary gland in equimolar proportions
Copeptin has a relatively short in vivo half-life of about 25 minutes as does MVA but is more stable in vitro when blood has been drawn
Its use in the early diagnosis of diabetes insipidus after pituitary surgery could therefore be of interest
Detailed Description:
Objective is to study the interest of copeptin dosage as an early predictive marker for the diagnosis of post-operatice diabetes insipidus in trans-sphenoidal endoscopic pituitary surgery
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