OTHER
Hypertonic 3% saline
Participants receive 10 ml/kg body weight of 3% saline infused over 1 hour. The aim is to stimulate copeptin release.
Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging
Status
Completed
Phase
Not applicable
Enrollment
32
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP. Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing. Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age. This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.
Interventions
Treatment arms and agents.
OTHER
Water
Participants ingest 20 ml/kg water over 1h. The aim is to suppress copeptin release.
Timeline
From registration to results.
First posted
Apr 16, 2025
Study start
Apr 30, 2025
Primary completion
Oct 10, 2025
Study completion
Oct 10, 2025
Results posted
Not reported
Registry updated
Jan 13, 2026
Outcomes
What the study measures.
Primary outcomes
Range of Variation in Copeptin
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
The primary outcome is the range of variation in copeptin, i.e. difference of suppressed copeptin to the stimulated copeptin, in healthy elderly participants compared to young controls.
Secondary outcomes
Changes in Copeptin upon stimulation and suppression
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Differences in total body water (L) measured by body impedance analysis
Time frame · at Baseline
Changes in cortisol (mmol/L)
Time frame · Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in blood pressure (mmHg)
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in heart rate
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma sodium (mmol/L)
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma potassium (mmol/L)
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma chloride (mmol/L)
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Changes in plasma osmolality (mOsm/kg)
Time frame · Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18-30 years or ≥ 60 years * Normonatremia (135-145 mmol/L) * Plasma osmolality 280-300 mOsm/kg * BMI ≥18 and ≤ 30 kg/m2 Exclusion Criteria: * Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.) * Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy * Pacemaker or ICD * History of thrombosis * Active oncologic disease * Heart failure * Liver cirrhosis * Estimated glomerular filtration rate (eGFR) \< 60 ml/kg/1.73 m2 * Uncontrolled hypertension \>160 mmHg systolic or \>100 mmHg diastolic * Polydipsia (ingestion of \>3L fluids per day) and polyuria (\>50 ml/kg urine production within 24 hours) * Pregnancy or breastfeeding * Participation in a study with investigational drugs within 30 days * Acute illness * Inability to follow study procedures
Study locations
1 registered sites.
Switzerland. Showing up to 24 locations stored in the fast local snapshot.
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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