Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)
17. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
144
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Talitha Hildebrandt
- Telefonnummer: +41 61 55 65075
- E-post: talithanatalja.hildebrandt@usb.ch
Studer Kontakt Backup
- Navn: Cemile Bathelt
- Telefonnummer: +41 61 55 65407
- E-post: cemile.bathelt@usb.ch
Studiesteder
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-
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Basel, Sveits, 4031
- Rekruttering
- University Hospital Basel
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Hovedetterforsker:
- Mirjam Christ-Crain, Prof. Dr.
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Ta kontakt med:
- Talitha Hildebrandt
- Telefonnummer: +41 61 55 65075
- E-post: talithanatalja.hildebrandt@usb.ch
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- 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:
- Polyuria/polydipsia secondary to diabetes mellitus, hypercalcemia, or hypokalemia
- Diagnosis of AVP-R (Copeptin > 21.4 pmol/L)
- Evidence of acute illness
- Epilepsy requiring treatment
- Uncontrolled arterial hypertension (blood pressure >160/100mmHg at baseline
- eGFR < 60 ml/min/1,73 m2
- Cardiac failure (NYHA III-IV)
- Diagnosis of liver cirrhosis, Child-Pugh Class C
- Uncorrected adrenal or thyroidal deficiency
- Pregnancy or breastfeeding
- Current or unresolved urinary obstruction
- Enrollment in a clinical trial within the last 30 days
- Patients refusing or unable to give written informed consent
- Inability to follow study procedures
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
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Intravenous infusion of 1.5g/kg body weight (max.
120g) mannitol is given over 30 minutes (≙ 7.5ml/kg body weight).
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Aktiv komparator: Hypertonic Saline Infusion (HIS)
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after HIS
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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).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Diagnostic Accuracy
Tidsramme: One time assessment at Follow up Visit 2 (10 weeks after baseline)
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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.
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One time assessment at Follow up Visit 2 (10 weeks after baseline)
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Patient Test Preference
Tidsramme: 1 week after completion of both diagnostic tests
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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).
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1 week after completion of both diagnostic tests
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Diagnostic Performance Measures for AVP-D
Tidsramme: At completion of follow-up, 10 weeks after last diagnostic test
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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.
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At completion of follow-up, 10 weeks after last diagnostic test
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Diagnostic Performance Measures for PP
Tidsramme: At completion of follow-up, 10 weeks after last diagnostic test
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Sensitivity, specificity, positive predictive value, and negative predictive value of mannitol infusion and hypertonic saline infusion for diagnosing PP using predefined copeptin cut-offs.
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At completion of follow-up, 10 weeks after last diagnostic test
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Optimal copeptin cut-off after mannitol infusion
Tidsramme: At completion of follow-up, 10 weeks after last diagnostic test
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Exploratory determination and validation of optimal copeptin cut-off values for differentiating AVP deficiency from primary polydipsia following mannitol stimulation.
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At completion of follow-up, 10 weeks after last diagnostic test
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Frequency and severity of clinical symptoms
Tidsramme: During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes)
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Frequency and severity of symptoms (e.g., thirst, headache, nausea, malaise) assessed using numeric rating scales during mannitol and hypertonic saline tests.
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During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes)
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Subjective burden of each test assessed by numeric rating scale
Tidsramme: Immediately after each test day
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Patient-reported burden of each diagnostic test assessed using a numeric rating scale (NRS) (0-10).
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Immediately after each test day
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Psychopathological assessment (STAI-T)
Tidsramme: 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.
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Baseline
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Autistic traits
Tidsramme: 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.
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Baseline
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Quality of Life in Posterior Pituitary Disease
Tidsramme: 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.
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Baseline and follow-up (10 weeks )
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Change in oxytocin/neurophysin I levels
Tidsramme: Baseline and 90 minutes post-stimulation
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Change in circulating oxytocin and neurophysin I levels before and after each diagnostic test.
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Baseline and 90 minutes post-stimulation
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Spearman's rank correlation coefficient between psychopathology questionnaires and oxytocin levels
Tidsramme: Baseline and 90 minutes post-stimulation
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Correlation between psychopathological questionnaires and oxytocin levels will be described using Spearman's rank correlation coefficient.
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Baseline and 90 minutes post-stimulation
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Spearman's rank correlation coefficient between psychopathology questionnaire and neurophysin I levels
Tidsramme: Baseline and 90 minutes post-stimulation
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Correlation between psychopathological questionnaires and neurophysin I levels will be described using Spearman's rank correlation coefficient.
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Baseline and 90 minutes post-stimulation
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Validation of clinical diagnostic score
Tidsramme: After test day 2 and 10 weeks thereafter
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Validation of a predefined diagnostic score using clinical and basal parameters
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After test day 2 and 10 weeks thereafter
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Change of urinary copeptin levels
Tidsramme: During test day 1 and test day 2 with a maximum of 3 month in between the two test days
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Change in urinary copeptin levels before and after mannitol and hypertonic saline stimulation.
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During test day 1 and test day 2 with a maximum of 3 month in between the two test days
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Optimal urinary copeptin cut-offs
Tidsramme: 10 weeks after test day 2
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Exploratory determination of optimal urinary copeptin thresholds for differential diagnosis.
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10 weeks after test day 2
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Sex-specific copeptin response
Tidsramme: During test day 1 and test day 2 with a maximum of 3 month in between the two test days and at study completion
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Evaluation of sex-specific differences in stimulated copeptin levels and corresponding diagnostic cut-offs.
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During test day 1 and test day 2 with a maximum of 3 month in between the two test days and at study completion
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Cost-efficiency of diagnostic tests
Tidsramme: One time assessment at Follow up Visit 2 (10 weeks after baseline)
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Exploratory assessment of healthcare costs associated with mannitol infusion versus hypertonic saline infusion.
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One time assessment at Follow up Visit 2 (10 weeks after baseline)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. juni 2026
Primær fullføring (Antatt)
1. juni 2030
Studiet fullført (Antatt)
1. juni 2030
Datoer for studieregistrering
Først innsendt
30. mars 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Sykdommer i det endokrine systemet
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Atferdssymptomer
- Hypofyse sykdommer
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Polydipsi
- Diabetes Insipidus
- Diabetes Insipidus, nevrogen
- Polydipsi, psykogen
Andre studie-ID-numre
- 2026-00480;kt25ChristCrain7
Legemiddel- og utstyrsinformasjon, studiedokumenter
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