Arginin-stimulated Copeptin in Polyuria-polydipsia Syndrome in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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 \> 3.53 pmol/l (Se 100%, Sp 87.4%), respectively). Below 3.53 pmol/l, 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 pmol/l) 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.

Eligibility criteria

Qualifiers

Children aged 2 to 18 years with polyuro-polydipsia syndrome (defined as hypotonic diuresis &gt; 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.

Disqualifiers

Diabetes mellitus

Unbalanced dysthyroidism

Corticotropic deficiency

Ionic disorders (dysnatremia &lt; 135 or &gt; 145 mmol/l, dyskalemia &lt; 3 or &gt; 5 mmol/l, corrected dyscalcemia &lt; 2.2 or &gt; 2.6 mmol/L)

Trial design

Treatments tested in this trial

  • Measure of Basal Copeptin level
  • Measure of arginine-stimulated copeptin
  • IRM
  • Water reduction at home

Treatment groups

155 Participants
are divided into 1 treatment group