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

17 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Zwitserland
      • Basel, Zwitserland, 4031
        • Werving
        • University Hospital Basel
        • Hoofdonderzoeker:
          • Mirjam Christ-Crain, Prof. Dr.
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
Diagnostische toets: Mannitol
Intravenous infusion of 1.5g/kg body weight (max. 120g) mannitol is given over 30 minutes (≙ 7.5ml/kg body weight).
Actieve vergelijker: Hypertonic Saline Infusion (HIS)
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after HIS
Diagnostische toets: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Diagnostic Accuracy
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Performance Measures for AVP-D
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Basel, Switzerland

Onderzoekers

  • Studie stoel: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 juni 2026

Primaire voltooiing (Geschat)

1 juni 2030

Studie voltooiing (Geschat)

1 juni 2030

Studieregistratiedata

Eerst ingediend

30 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

6 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-00480;kt25ChristCrain7

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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