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Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)

17 juin 2026 mis à jour par: University Hospital, Basel, Switzerland
The aim of this study is to evaluate whether a new test using mannitol infusion can diagnose the cause of polyuria-polydipsia syndrome as accurately as the current standard test (hypertonic saline infusion) and to compare which test patients prefer. The goal is to identify a simpler and more patient-friendly diagnostic approach.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Polyuria-polydipsia syndrome (PPS), characterized by excessive urination and fluid intake, can have different underlying causes, including a deficiency of the hormone vasopressin (AVP-D) or excessive fluid intake without AVP-D (primary polydipsia). Correctly identifying the cause is essential, as the treatments differ and an incorrect diagnosis can negatively impact patient care.

A blood marker called copeptin is used to support the diagnosis, as it reflects vasopressin levels in the body. Currently, the most accurate method involves measuring copeptin after stimulation with hypertonic saline. However, this test is complex, requires close medical monitoring, and can be uncomfortable for patients.

Mannitol is a substance already used in routine clinical care and may offer a simpler way to stimulate copeptin release. Early results suggest that it could provide similar diagnostic accuracy with fewer side effects and better patient comfort.

This study is a randomized, cross-over, multicenter trial in which participants undergo both tests (mannitol and hypertonic saline) in random order. The study compares the diagnostic accuracy and patient preference for both methods, as well as safety and tolerability. In addition, it explores whether other clinical and laboratory measures can further improve the diagnosis of PPS.

Type d'étude

Interventionnel

Inscription (Estimé)

144

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Suisse
      • Basel, Suisse, 4031
        • Recrutement
        • University Hospital Basel
        • Chercheur principal:
          • Mirjam Christ-Crain, Prof. Dr.
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Hypotonic polyuria/polydipsia syndrome defined as polyuria >40ml/kg body weight/24h and polydipsia >3l/24h; and urine osmolality <800mOsm/L or known AVP-D based on accepted criteria

Exclusion Criteria:

  1. Polyuria/polydipsia secondary to diabetes mellitus, hypercalcemia, or hypokalemia
  2. Diagnosis of AVP-R (Copeptin > 21.4 pmol/L)
  3. Evidence of acute illness
  4. Epilepsy requiring treatment
  5. Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline
  6. eGFR < 60 ml/min/1,73 m2
  7. Cardiac failure (NYHA III-IV)
  8. Diagnosis of liver cirrhosis, Child-Pugh Class C
  9. Uncorrected adrenal or thyroidal deficiency
  10. Pregnancy or breastfeeding
  11. Current or unresolved urinary obstruction
  12. Enrollment in a clinical trial within the last 30 days
  13. Patients refusing or unable to give written informed consent
  14. Inability to follow study procedures

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
Test diagnostique: Mannitol
Intravenous infusion of 1.5g/kg body weight (max. 120g) mannitol is given over 30 minutes (≙ 7.5ml/kg body weight).
Comparateur actif: Hypertonic Saline Infusion (HIS)
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after HIS
Test diagnostique: Hypertonic Saline
Intravenous infusion of NaCl 3% is given first as a bolus of 250ml over 15 minutes, then with an infusion rate of 0.15ml/kg body weight / minute (≙ 9ml/kg body weight/hour).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Diagnostic Accuracy
Délai: One time assessment at Follow up Visit 2 (10 weeks after baseline)
The overall diagnostic accuracy is defined as the proportion of correct diagnoses out of all diagnoses based on the stimulated copeptin value. Final diagnosis will be made after termination of the study by two endocrine specialists who will be blinded to the copeptin results of the mannitol infusion.
One time assessment at Follow up Visit 2 (10 weeks after baseline)
Patient Test Preference
Délai: 1 week after completion of both diagnostic tests
Patient-reported preference between mannitol infusion and hypertonic saline infusion, assessed using a 5-point Likert scale ranging from -2 (strong preference for hypertonic saline) to +2 (strong preference for mannitol).
1 week after completion of both diagnostic tests

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diagnostic Performance Measures for AVP-D
Délai: At completion of follow-up, 10 weeks after last diagnostic test
Sensitivity, specificity, positive predictive value, and negative predictive value of mannitol infusion and hypertonic saline infusion for diagnosing AVP deficiency using predefined copeptin cut-offs.
At completion of follow-up, 10 weeks after last diagnostic test
Diagnostic Performance Measures for PP
Délai: At completion of follow-up, 10 weeks after last diagnostic test
Sensitivity, specificity, positive predictive value, and negative predictive value of mannitol infusion and hypertonic saline infusion for diagnosing PP using predefined copeptin cut-offs.
At completion of follow-up, 10 weeks after last diagnostic test
Optimal copeptin cut-off after mannitol infusion
Délai: At completion of follow-up, 10 weeks after last diagnostic test
Exploratory determination and validation of optimal copeptin cut-off values for differentiating AVP deficiency from primary polydipsia following mannitol stimulation.
At completion of follow-up, 10 weeks after last diagnostic test
Frequency and severity of clinical symptoms
Délai: During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes)
Frequency and severity of symptoms (e.g., thirst, headache, nausea, malaise) assessed using numeric rating scales during mannitol and hypertonic saline tests.
During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes)
Subjective burden of each test assessed by numeric rating scale
Délai: Immediately after each test day
Patient-reported burden of each diagnostic test assessed using a numeric rating scale (NRS) (0-10).
Immediately after each test day
Psychopathological assessment (STAI-T)
Délai: Baseline
General anxiety levels is assessed by State-Trait Anxiety Inventory (STAI-T) questionnaire. The total trait score (STAI-T) ranges from 20 to 80, with higher scores indicating more pronounced anxiety.
Baseline
Autistic traits
Délai: Baseline
Autistic traits is assessed by Autism-Spectrum Quotient (AQ) questionnaire. The AQ consists of 50 items, with four choices for each item from "definitely agree" to "definitely disagree" and a total score from 0 to 50. A score above the proposed cut-off of 29 highlights significant traits of autism.
Baseline
Quality of Life in Posterior Pituitary Disease
Délai: Baseline and follow-up (10 weeks )
Currently, no disease-specific tool exists to assess treatment success for either desmopressin or oxytocin (OXT) therapy in patients with arginine vasopressin deficiency (AVP-D). To address this gap, we developed a novel multidimensional questionnaire in close collaboration with patients, patient representatives, and patient advocates. The PP-QoL consists of three parts: Part A assesses symptoms related to AVP-D (15 items), while Parts B (17 items) and C (21 items) focus on domains associated with OXT deficiency.
Baseline and follow-up (10 weeks )
Change in oxytocin/neurophysin I levels
Délai: Baseline and 90 minutes post-stimulation
Change in circulating oxytocin and neurophysin I levels before and after each diagnostic test.
Baseline and 90 minutes post-stimulation
Spearman's rank correlation coefficient between psychopathology questionnaires and oxytocin levels
Délai: Baseline and 90 minutes post-stimulation
Correlation between psychopathological questionnaires and oxytocin levels will be described using Spearman's rank correlation coefficient.
Baseline and 90 minutes post-stimulation
Spearman's rank correlation coefficient between psychopathology questionnaire and neurophysin I levels
Délai: Baseline and 90 minutes post-stimulation
Correlation between psychopathological questionnaires and neurophysin I levels will be described using Spearman's rank correlation coefficient.
Baseline and 90 minutes post-stimulation
Validation of clinical diagnostic score
Délai: After test day 2 and 10 weeks thereafter
Validation of a predefined diagnostic score using clinical and basal parameters
After test day 2 and 10 weeks thereafter
Change of urinary copeptin levels
Délai: During test day 1 and test day 2 with a maximum of 3 month in between the two test days
Change in urinary copeptin levels before and after mannitol and hypertonic saline stimulation.
During test day 1 and test day 2 with a maximum of 3 month in between the two test days
Optimal urinary copeptin cut-offs
Délai: 10 weeks after test day 2
Exploratory determination of optimal urinary copeptin thresholds for differential diagnosis.
10 weeks after test day 2
Sex-specific copeptin response
Délai: During test day 1 and test day 2 with a maximum of 3 month in between the two test days and at study completion
Evaluation of sex-specific differences in stimulated copeptin levels and corresponding diagnostic cut-offs.
During test day 1 and test day 2 with a maximum of 3 month in between the two test days and at study completion
Cost-efficiency of diagnostic tests
Délai: One time assessment at Follow up Visit 2 (10 weeks after baseline)
Exploratory assessment of healthcare costs associated with mannitol infusion versus hypertonic saline infusion.
One time assessment at Follow up Visit 2 (10 weeks after baseline)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Basel, Switzerland

Les enquêteurs

  • Chaise d'étude: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 juin 2026

Achèvement primaire (Estimé)

1 juin 2030

Achèvement de l'étude (Estimé)

1 juin 2030

Dates d'inscription aux études

Première soumission

30 mars 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-00480;kt25ChristCrain7

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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