Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Mannitol, Hypertonic Saline.
- Кому может быть актуально
- Состояния в реестре: Arginine Vasopressin Deficiency, Primary Polydipsia. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест Mannitol
Intravenous infusion of 1.5g/kg body weight (max. 120g) mannitol is given over 30 minutes (≙ 7.5ml/kg body weight). - Диагностический тест 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).
Первичные конечные точки
- Overall Diagnostic Accuracy [Срок оценки: One time assessment at Follow up Visit 2 (10 weeks after baseline)]
- Patient Test Preference [Срок оценки: 1 week after completion of both diagnostic tests]
Вторичные конечные точки (12)
- Diagnostic Performance Measures for AVP-D [Срок оценки: At completion of follow-up, 10 weeks after last diagnostic test]
- Diagnostic Performance Measures for PP [Срок оценки: At completion of follow-up, 10 weeks after last diagnostic test]
- Optimal copeptin cut-off after mannitol infusion [Срок оценки: At completion of follow-up, 10 weeks after last diagnostic test]
- Frequency and severity of clinical symptoms [Срок оценки: During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes)]
- Subjective burden of each test assessed by numeric rating scale [Срок оценки: Immediately after each test day]
- Psychopathological assessment (STAI-T) [Срок оценки: Baseline]
- Autistic traits [Срок оценки: Baseline]
- Quality of Life in Posterior Pituitary Disease [Срок оценки: Baseline and follow-up (10 weeks )]
- Change in oxytocin/neurophysin I levels [Срок оценки: Baseline and 90 minutes post-stimulation]
- Spearman's rank correlation coefficient between psychopathology questionnaires and oxytocin levels [Срок оценки: Baseline and 90 minutes post-stimulation]
- Spearman's rank correlation coefficient between psychopathology questionnaire and neurophysin I levels [Срок оценки: Baseline and 90 minutes post-stimulation]
- Validation of clinical diagnostic score [Срок оценки: After test day 2 and 10 weeks thereafter]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Швейцария · 1 центр
- University Hospital Basel — Basel
Идентификаторы
NCT: NCT07569861 · 2026-00480;kt25ChristCrain7