Status:
NOT_YET_RECRUITING
Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Primary Polydipsia
Central Diabetes Insipidus
Eligibility:
All Genders
2-18 years
Phase:
NA
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 in...
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 pmol/...
Eligibility Criteria
Inclusion
- Children aged 2 to 18 years with polyuro-polydipsia syndrome (defined as hypotonic diuresis \> 50 mL/kg/day in pediatric age or 30 mL/kg/day in late puberty (Tanner 5)) presenting for differential diagnosis between PP and DIC
- Basal copeptin of less than 30 pmol/l
- Agreeing to participate in the study
- Whose two parents' consent to have their child participate in the study.
Exclusion
- Diabetes mellitus
- Unbalanced dysthyroidism
- Corticotropic deficiency
- Ionic disorders (dysnatremia \< 135 or \> 145 mmol/l, dyskalemia \< 3 or \> 5 mmol/l, corrected dyscalcemia \< 2.2 or \> 2.6 mmol/L)
- Moderate to severe clinical dehydration (recent weight loss \> 5% of body weight, clinical or biological signs of dehydration) requiring immediate therapeutic management
- Renal failure with GFR \< 60 mL/min/1.73 m2
- Uropathy
- Tumor syndrome (except hypothalamo-pituitary tumor)
- Intracranial hypertension
- ROHHAD syndrome
- Fever or biological inflammatory syndrome with CRP \> 5 mg/L
- Hepatic insufficiency
- Contraindication to MRI
- Contraindication to progressive water intake restrictions
- History of contraindication to arginine
- Positive test for Pregnancy
- Lack of authorization by both parents or legal representatives
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT06604975
Start Date
March 1 2025
End Date
July 1 2028
Last Update
February 13 2025
Active Locations (14)
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1
CHU Angers
Angers, France
2
CHU de Bordeaux
Bordeaux, France
3
CHU Lille
Lille, France
4
HCL
Lyon, France