Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)
2026年6月17日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
144
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Talitha Hildebrandt
- 电话号码：+41 61 55 65075
- 邮箱：talithanatalja.hildebrandt@usb.ch
研究联系人备份
- 姓名：Cemile Bathelt
- 电话号码：+41 61 55 65407
- 邮箱：cemile.bathelt@usb.ch
学习地点
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Basel、瑞士、4031
- 招聘中
- University Hospital Basel
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首席研究员：
- Mirjam Christ-Crain, Prof. Dr.
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接触：
- Talitha Hildebrandt
- 电话号码：+41 61 55 65075
- 邮箱：talithanatalja.hildebrandt@usb.ch
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Diagnostic Accuracy
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic Performance Measures for AVP-D
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Mirjam Christ-Crain, Prof. Dr.、University Hospital of Basel
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月16日
初级完成 (估计的)
2030年6月1日
研究完成 (估计的)
2030年6月1日
研究注册日期
首次提交
2026年3月30日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月6日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-00480;kt25ChristCrain7
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