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Completed

NCT Number: NCT06930300

Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging

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.

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Key information

Conditions

Healthy Ageing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic 3% saline

Other

Participants receive 10 ml/kg body weight of 3% saline infused over 1 hour. The aim is to stimulate copeptin release.

Water

Other

Participants ingest 20 ml/kg water over 1h. The aim is to suppress copeptin release.

Primary outcomes

  1. 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

  1. 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

  2. Differences in total body water (L) measured by body impedance analysis

    Time frame: at Baseline

  3. Changes in cortisol (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Changes in estimated glomerular filtration rate (ml/kg/1.73m2)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  12. Changes in plasma glucose (mmol/L)

    Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  13. Changes in plasma urea (mmol/L)

    Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  14. Changes in plasma uric acid (umol/L)

    Time frame: Baseline, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  15. Changes in urine osmolality (mOsm/kg)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  16. Changes in urine sodium (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  17. Changes in urine potassium (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  18. Changes in urine chloride (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  19. Changes in urine urea (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  20. Changes in urine uric acid (umol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  21. Changes in urine glucose (mmol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

  22. Changes in urine creatinine (umol/L)

    Time frame: Baseline, 60 minutes, and 120 minutes both after saline administration and after water ingestion

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: VENUS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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