Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)
17 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
144
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Talitha Hildebrandt
- Número de teléfono: +41 61 55 65075
- Correo electrónico: talithanatalja.hildebrandt@usb.ch
Copia de seguridad de contactos de estudio
- Nombre: Cemile Bathelt
- Número de teléfono: +41 61 55 65407
- Correo electrónico: cemile.bathelt@usb.ch
Ubicaciones de estudio
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Basel, Suiza, 4031
- Reclutamiento
- University Hospital Basel
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Investigador principal:
- Mirjam Christ-Crain, Prof. Dr.
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Contacto:
- Talitha Hildebrandt
- Número de teléfono: +41 61 55 65075
- Correo electrónico: talithanatalja.hildebrandt@usb.ch
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Diagnostic Accuracy
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic Performance Measures for AVP-D
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Baseline
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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
Periodo de tiempo: Baseline
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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
Periodo de tiempo: Baseline and follow-up (10 weeks )
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2030
Finalización del estudio (Estimado)
1 de junio de 2030
Fechas de registro del estudio
Enviado por primera vez
30 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de mayo de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del sistema endocrino
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Síntomas de comportamiento
- Enfermedades de la pituitaria
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Polidipsia
- Diabetes insípida
- Diabetes Insípida Neurogénica
- Polidipsia Psicógena
Otros números de identificación del estudio
- 2026-00480;kt25ChristCrain7
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .