Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children

NANot yet recruitingINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

July 31, 2028

Conditions
Primary PolydipsiaCentral Diabetes InsipidusNephrogenic Diabetes Insipidus
Interventions
PROCEDURE

Measure of Basal Copeptin level

"Copeptin test is performed after solid fasting since midnight without water restriction. After blood collection on heparin tube used for biological inclusion criteria, heparinized plasma is transferred to Timone University hospital (transport temperature +4°C) for screening copeptin assay.~The basal copeptin level determines the next step:~1. copeptin ≥ 30 pmol/L defines the diagnosis of NDI and results in a specific care;~2. copeptin \< 30 pmol/L defines the group of eligible patients for arginine stimulation"

PROCEDURE

Measure of arginine-stimulated copeptin

The arginine-stimulated copeptin test start at 8 am, after solid fasting since midnight without water restriction, and 30 min of rest in decubitus position. A dose of 0.5 g/kg of arginine (maximum 40g) diluted in 0.9% NaCl is infused over 30 min through a peripheral venous line. Copeptin is measured at T0 (before infusion), T45, T60, T90, and T120 min after infusion.

PROCEDURE

IRM

"Based on our previous study, patients with basal copeptin value over 3.53 pmol/L are considered as positive diagnosis of PP (Se 100%, Sp 87.4%) and cerebral MRI is not performed for this group of patients (PP group).~A cerebral and pituitary MRI performed according to reference procedures (without and with contrast medium used in routine care) for patients considered as an uncertain diagnosis (UD) based on basal copeptin value (\< 3.53 pmol/L). MRI interpretation is performed by two independent neuroradiologists (one from the recruiting center and one from the pilot center). In case of discrepancies, a third independent interpretation will be performed by a neuroradiologist from the coordinating center. Abnormal pituitary MRI (thickened pituitary stalk pituitary tumor, ectopic neurohypophysis, septo-optic dysplasia, empty sellar, Rathke pouch) allows a diagnosis of CDI leading to etiological investigations and AVP treatment."

BEHAVIORAL

Water reduction at home

Patients with basal copeptin ≥ 3.53 pmol/l (PP group), and UD patients with normal MRI have gradual reduction of water intake at home without AVP treatment : gradual reduction with 20% in the first week, 30% in the second, 40% in the third, reaching 50% of daily fluid in the last week including restriction overnight, deletion drink before sleep. Some recommendations will be provided to help physicians. For all these latest patients, a clinical reassessment (weight, height, heart rate, blood pressure, input/output 24 hours balance) is performed one month later.

Trial Locations (14)

Unknown

CHU Angers, Angers

CHU de Bordeaux, Bordeaux

CHU Lille, Lille

HCL, Lyon

Assistance Publique Hopitaux de Marseille, Marseille

CHU Montpellier, Montpellier

CHU Nantes, Nantes

CHU Nice, Nice

AP-HP, Paris

CH Pau, Pau

CHU Reims, Reims

CHU Rennes, Rennes

CHU Rouen, Rouen

CHU Toulouse, Toulouse

All Listed Sponsors
lead

Assistance Publique Hopitaux De Marseille

OTHER