Clinical Trials Directory

Trials / Completed

CompletedNCT04326569

Copeptin in the Diagnosis of Post-operative Insipidus Diabetes After Pituitary Surgery

Interest of the Copeptine Dosage in Diagnosis of Post-operative Insipidus Diabetes After Transsphenoidal Pituitary Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
57 (actual)
Sponsor
CHU de Reims · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERBlood sampleBlood sample to quantify copeptin

Timeline

Start date
2022-01-03
Primary completion
2024-03-18
Completion
2024-03-18
First posted
2020-03-30
Last updated
2024-06-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04326569. Inclusion in this directory is not an endorsement.