Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)
17 juni 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
144
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Talitha Hildebrandt
- Telefonnummer: +41 61 55 65075
- E-post: talithanatalja.hildebrandt@usb.ch
Studera Kontakt Backup
- Namn: Cemile Bathelt
- Telefonnummer: +41 61 55 65407
- E-post: cemile.bathelt@usb.ch
Studieorter
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-
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Basel, Schweiz, 4031
- Rekrytering
- University Hospital Basel
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Huvudutredare:
- Mirjam Christ-Crain, Prof. Dr.
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Kontakt:
- Talitha Hildebrandt
- Telefonnummer: +41 61 55 65075
- E-post: talithanatalja.hildebrandt@usb.ch
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Diagnostic Accuracy
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Diagnostic Performance Measures for AVP-D
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
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Autistic traits
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Baseline and 90 minutes post-stimulation
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Spearman's rank correlation coefficient between psychopathology questionnaire and neurophysin I levels
Tidsram: 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
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Validation of clinical diagnostic score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
One time assessment at Follow up Visit 2 (10 weeks after baseline)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 juni 2026
Primärt slutförande (Beräknad)
1 juni 2030
Avslutad studie (Beräknad)
1 juni 2030
Studieregistreringsdatum
Först inskickad
30 mars 2026
Först inskickad som uppfyllde QC-kriterierna
4 maj 2026
Första postat (Faktisk)
6 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
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Nyckelord
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- Beteendesymtom
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- Beteende
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- Polydipsi
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- Polydipsi, psykogen
Andra studie-ID-nummer
- 2026-00480;kt25ChristCrain7
Läkemedels- och apparatinformation, studiedokument
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