Copeptin Measurement After Mannitol and Hypertonic Saline for the Diagnosis of Polyuria-polydipsia Syndrome (COMPASS)
2026년 5월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
144
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Talitha Hildebrandt
- 전화번호: +41 61 55 65075
- 이메일: talithanatalja.hildebrandt@usb.ch
연구 연락처 백업
- 이름: Cemile Bathelt
- 전화번호: +41 61 55 65407
- 이메일: cemile.bathelt@usb.ch
연구 장소
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Basel, 스위스, 4031
- University Hospital Basel
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수석 연구원:
- Mirjam Christ-Crain, Prof. Dr.
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연락하다:
- Talitha Hildebrandt
- 전화번호: +41 61 55 65075
- 이메일: talithanatalja.hildebrandt@usb.ch
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Diagnostic Accuracy
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Performance Measures for AVP-D
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Mirjam Christ-Crain, Prof. Dr., University Hospital of Basel
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2030년 6월 1일
연구 완료 (추정된)
2030년 6월 1일
연구 등록 날짜
최초 제출
2026년 3월 30일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 4일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-00480;kt25ChristCrain7
약물 및 장치 정보, 연구 문서
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아니
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