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To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia
Achieving recommended treatment targets in management of hyponatremia is challenging: plasma sodium must be increased effectively but, at the same time, overcorrection has to be prevented. Yet, predictors of change of sodium over time have not been delineated properly. It was found, that evidence hinting to the fact that sodium baseline itself is crucial with respect to sodium evolution.
The goal of this study is to gather prospective data in order to precisely delineate the role of initial sodium levels by correlating those to plasma sodium evolution and electrolyte free water evolution. It is aimed to decipher patterns of sodium evolution with respect to anthropometric data, such as body composition analyses and blood pressure and markers of innate regulation mechanisms of body volume like aldosterone and renin. In addition, apart from these clinical aspects, a better appreciation of the physiological responses to hyponatremia treatment in terms of water and electrolyte balances is undoubtedly necessary to improve understanding of the body's mechanisms involved in osmotic homeostasis and cell volume control. Since studies to date also lack consideration of the intracellular department, the aim is to close that gap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with non-hypervolemic hypotonic hyponatremia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients | Other | Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Plasma Sodium | Measurement of plasma sodium in blood samples | baseline, every day up to 30 days |
| Changes in plasma osmolality | Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment | baseline, every day up to 30 days |
| Changes in urine osmolality | Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality | baseline, every day up to 30 days |
| Changes in urine volume | Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume | baseline, every day up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement | baseline, every day up to 30 days |
| Changes in total body water | Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement |
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Inclusion Criteria:
Adult patients ≥ 18 years
Hypotonic hyponatremia
Exclusion Criteria:
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Patients with non-hypervolemic hyponatremia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Volker Burst, MD, Prof | Contact | +49 221-478-97222 | volker.burst@uk-koeln.de | |
| Sadrija Cukoski | Contact | sadrija.cukoski@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Volker Burst, MD, Prof. | University Hospital of Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Cologne | Recruiting | Cologne | 50937 | Germany |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Blood, urine
| baseline, every day up to 30 days |
| Changes in intracellular volume | Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement | baseline, every day up to 30 days |
| Changes in extracellular volume | Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement | baseline, every day up to 30 days |
| Changes in blood pressure | Measurement of blood pressure before, during and after hyponatremia treatment | baseline, every day up to 30 days |
| Changes in cell size | Determination of blood cell size via measurement of mean corpuscular volume | baseline, every day up to 30 days |
| Changes in intracellular electrolyte levels | Measurement of whole blood samples via ICP-mass spectrometry | baseline, every day up to 30 days |
| Changes in copeptin levels | Measurement of copeptin in blood samples | baseline, every day up to 30 days |
| Changes in renin levels | Measurement of renin in blood samples | baseline, every day up to 30 days |
| Changes in aldosterone levels | Measurement of aldosterone in blood samples | baseline, every day up to 30 days |