Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
- Conditions
- Non-hypervolemic Hyponatremia
- Interventions
- Other: Patients
- Registration Number
- NCT05692726
- Lead Sponsor
- University of Cologne
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
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
- Signs of extracellular volume expansion
- Patients with liver cirrhosis and severe liver damage AST/ALT>3xULN, AP>6xULN, Bilirubin ≥ 3mg/dl
- Patients with heart failure
- Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl
- Patients after organ transplantation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Patients Patients with non-hypervolemic hypotonic hyponatremia
- Primary Outcome Measures
Name Time Method 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 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 Plasma Sodium baseline, every day up to 30 days Measurement of plasma sodium in blood samples
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
Name Time Method 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 blood pressure baseline, every day up to 30 days Measurement of blood pressure before, during and after hyponatremia treatment
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
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 extracellular volume baseline, every day up to 30 days Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
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 total body water baseline, every day up to 30 days Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement
Trial Locations
- Locations (1)
University Hospital of Cologne
🇩🇪Cologne, Germany