Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Overall Diagnostic Accuracy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hypertonic Saline Infusion (HIS)
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after HIS
干预措施: Hypertonic Saline (Diagnostic Test)
Mannitol Infusion
Diagnostic evaluation of polyuria polydipsia syndrome through copeptin measurement after mannitol infusion.
干预措施: Mannitol (Diagnostic Test)
结局指标
主要结局
Overall Diagnostic Accuracy
时间窗: One time assessment at Follow up Visit 2 (10 weeks after baseline)
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.
Patient Test Preference
时间窗: 1 week after completion of both diagnostic tests
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).
次要结局
- Diagnostic Performance Measures for AVP-D(At completion of follow-up, 10 weeks after last diagnostic test)
- Diagnostic Performance Measures for PP(At completion of follow-up, 10 weeks after last diagnostic test)
- Optimal copeptin cut-off after mannitol infusion(At completion of follow-up, 10 weeks after last diagnostic test)
- Frequency and severity of clinical symptoms(During each test day (baseline to end of monitoring period 90 minutes/ 240 minutes))
- Subjective burden of each test assessed by numeric rating scale(Immediately after each test day)
- Psychopathological assessment (STAI-T)(Baseline)
- Autistic traits(Baseline)
- Quality of Life in Posterior Pituitary Disease(Baseline and follow-up (10 weeks ))
- Change in oxytocin/neurophysin I levels(Baseline and 90 minutes post-stimulation)
- Spearman's rank correlation coefficient between psychopathology questionnaires and oxytocin levels(Baseline and 90 minutes post-stimulation)
- Spearman's rank correlation coefficient between psychopathology questionnaire and neurophysin I levels(Baseline and 90 minutes post-stimulation)
- Validation of clinical diagnostic score(After test day 2 and 10 weeks thereafter)
- Change of urinary copeptin levels(During test day 1 and test day 2 with a maximum of 3 month in between the two test days)
- Optimal urinary copeptin cut-offs(10 weeks after test day 2)
- Sex-specific copeptin response(During test day 1 and test day 2 with a maximum of 3 month in between the two test days and at study completion)
- Cost-efficiency of diagnostic tests(One time assessment at Follow up Visit 2 (10 weeks after baseline))