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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277336
Other study ID # 2023-01716; kt23ChristCrain3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 2025

Study information

Verified date April 2024
Source University Hospital, Basel, Switzerland
Contact Sven Lustenberger, MD.
Phone +41 61 328 62 64
Email sven.lustenberger@usb.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia. The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin. The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia. The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia.


Description:

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Study Design


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Intervention

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Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total urinary excretion (ml) Urinary excretion, in ml, between end of water loading and one hour past study infusion completion assessment between timepoint 0 hours and timepoint +4 hours
Secondary Hourly and total urinary excretion (ml) Change in urine volume, in ml assessment between timepoint -2 hours and timepoint +9 hours
Secondary Change in electrolyte free water clearance (ml/min) Change in electrolyte free water clearance, in ml/min assessment between timepoint -2 hours and timepoint +9 hours
Secondary Change in free water clearance (ml/min) Change in free water clearance, in ml/min assessment between timepoint -2 hours and timepoint +9 hours
Secondary Change in plasma osmolality (mOsm/kg) Change in plasma osmolality, in mOsm/kg assessment between baseline and timepoint +9 hours
Secondary Change in plasma sodium (mmol/l) Change in plasma sodium, in mmol/l assessment between baseline and timepoint +9 hours
Secondary Change in body weight (kg) Change in body weight, in kg assessment between baseline and timepoint +9 hours
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