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

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

144

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svizzera
      • Basel, Svizzera, 4031
        • University Hospital Basel
        • Investigatore principale:
          • Mirjam Christ-Crain, Prof. Dr.
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
Test diagnostico: Mannitol
Intravenous infusion of 1.5g/kg body weight (max. 120g) mannitol is given over 30 minutes (≙ 7.5ml/kg body weight).
Comparatore attivo: Hypertonic Saline Infusion (HIS)
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after HIS
Test diagnostico: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Diagnostic Accuracy
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Performance Measures for AVP-D
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Basel, Switzerland

Investigatori

  • Cattedra di studio: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2030

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

30 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-00480;kt25ChristCrain7

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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