Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)
NCT ID: NCT06542198
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2024-09-10
2025-07-22
Brief Summary
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Detailed Description
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Mannitol has been shown to stimulate AVP release, but no study has tested copeptin levels after mannitol stimulation in healthy adults or patients with AVP-D or PP.
This single-center study is conducted in two consecutive parts. Part 1 is a double-blind, randomized cross-over proof-of-concept study in healthy adults to investigate if mannitol infusion stimulates copeptin release. Part 2 is an open-label, single arm case-control pilot study in adults with diagnosed PP or AVP-D to see if copeptin levels after mannitol stimulation differ in PP and AVP-D.
The results of this study aim to demonstrate if mannitol infusion has the potential to be used as an alternative to hypertonic saline infusion.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy adults
Part 1 of the study is conducted with healthy adults.
Mannitol Infusion (blinded)
1 g of mannitol per kg body weight is infused in 30 minutes (≙ 5 ml/kg body weight), with an upper limit of 80 g, equivalent to a body weight of 80 kg or a volume of 400 ml. The solution used for infusion is 20% mannitol in water for injection and is administered at a rate of 0.17 ml/kg/min.
Placebo Infusion (blinded)
0.9% saline will be administered in the same amount as the mannitol dose infusion (= 5 ml/kg body weight), with a rate of 0.17 ml/kg/min in 30 minutes, with an upper limit of 400 ml (equivalent to a body weight of 80 kg).
Primary polydipsia (PP) patients
Part 2 of the study is conducted with PP patients.
Mannitol Infusion (open label)
1.5 g of mannitol per kg body weight is infused in 30 minutes (≙ 7.5 ml/kg body weight), with an upper limit of 120 g, equivalent to a body weight of 80 kg or a volume of 600 ml. The solution used for infusion is 20% mannitol in water for injection.
Arginine vasopressin deficiency (AVP-D) patients
Part 2 of the study is conducted with AVP-D patients.
Mannitol Infusion (open label)
1.5 g of mannitol per kg body weight is infused in 30 minutes (≙ 7.5 ml/kg body weight), with an upper limit of 120 g, equivalent to a body weight of 80 kg or a volume of 600 ml. The solution used for infusion is 20% mannitol in water for injection.
Interventions
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Mannitol Infusion (blinded)
1 g of mannitol per kg body weight is infused in 30 minutes (≙ 5 ml/kg body weight), with an upper limit of 80 g, equivalent to a body weight of 80 kg or a volume of 400 ml. The solution used for infusion is 20% mannitol in water for injection and is administered at a rate of 0.17 ml/kg/min.
Placebo Infusion (blinded)
0.9% saline will be administered in the same amount as the mannitol dose infusion (= 5 ml/kg body weight), with a rate of 0.17 ml/kg/min in 30 minutes, with an upper limit of 400 ml (equivalent to a body weight of 80 kg).
Mannitol Infusion (open label)
1.5 g of mannitol per kg body weight is infused in 30 minutes (≙ 7.5 ml/kg body weight), with an upper limit of 120 g, equivalent to a body weight of 80 kg or a volume of 600 ml. The solution used for infusion is 20% mannitol in water for injection.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Healthy with no medication except hormonal contraception
Part 2: Pilot Study in Patients with primary polydipsia (PP) or arginine vasopressin deficiency (AVP-D)
* Age ≥ 18 years
* Evidence of polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours or regular desmopressin medication corresponding to a diagnosis of PP or AVP-D
Exclusion Criteria
* Participation in a trial with investigational drugs within 30 days
* Evidence of disordered drinking habits and diuresis defined as polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours.
* Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1,73 m2
* Glucose \> 11.1 mmol/L corresponding to the diagnosis of an uncontrolled diabetes mellitus
* History of urinary tract obstruction
* Problems with urination
* Pregnancy or breastfeeding
* Multiple allergies (≥ 3)
* Evidence of acute illness
Part 2: Pilot Study in Patients with PP or AVP-D
* Participation in a trial with investigational drugs within 30 days
* Pregnancy or breastfeeding
* Evidence of acute illness
* eGFR \< 60 ml/min/1,73 m2
* Glucose \> 11.1 mmol/L corresponding to the diagnosis of uncontrolled diabetes mellitus
* History of urinary tract obstruction
* Problems with urination
* Therapy with diuretics
* Multiple allergies (≥ 3)
18 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Mirjam Christ-Crain, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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2024-01214; kt24ChristCrain
Identifier Type: -
Identifier Source: org_study_id
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