EvenT: Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
Study Details
Study Description
Brief Summary
To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Patients with non-hypervolemic hypotonic hyponatremia |
Other: Patients
Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge
|
Outcome Measures
Primary Outcome Measures
- Changes in Plasma Sodium [baseline, every day up to 30 days]
Measurement of plasma sodium in blood samples
- Changes in plasma osmolality [baseline, every day up to 30 days]
Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment
- Changes in urine osmolality [baseline, every day up to 30 days]
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality
- Changes in urine volume [baseline, every day up to 30 days]
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume
Secondary Outcome Measures
- Changes in body weight [baseline, every day up to 30 days]
Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement
- Changes in total body water [baseline, every day up to 30 days]
Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement
- Changes in intracellular volume [baseline, every day up to 30 days]
Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
- Changes in extracellular volume [baseline, every day up to 30 days]
Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
- Changes in blood pressure [baseline, every day up to 30 days]
Measurement of blood pressure before, during and after hyponatremia treatment
- Changes in cell size [baseline, every day up to 30 days]
Determination of blood cell size via measurement of mean corpuscular volume
- Changes in intracellular electrolyte levels [baseline, every day up to 30 days]
Measurement of whole blood samples via ICP-mass spectrometry
- Changes in copeptin levels [baseline, every day up to 30 days]
Measurement of copeptin in blood samples
- Changes in renin levels [baseline, every day up to 30 days]
Measurement of renin in blood samples
- Changes in aldosterone levels [baseline, every day up to 30 days]
Measurement of aldosterone in blood samples
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patients ≥ 18 years
-
Hypotonic hyponatremia
-
glucose-corrected plasma sodium <130 mmol/l
-
serum osmolality <280 mosmol/kg or lack of signs of non-hypotonic hyponatremia
Exclusion Criteria:
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Signs of extracellular volume expansion
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Patients with liver cirrhosis and severe liver damage AST/ALT>3xULN, AP>6xULN, Bilirubin ≥ 3mg/dl
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Patients with heart failure
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Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl
-
Patients after organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Cologne | Cologne | Germany | 50937 |
Sponsors and Collaborators
- University of Cologne
Investigators
- Principal Investigator: Volker Burst, MD, Prof., University Hospital of Cologne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V1.0-20220315