Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients.
- Who it may be relevant to
- Registry conditions: Non-hypervolemic Hyponatremia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
Overview
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.
Interventions
- Other Patients
Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge
Primary outcome measures
- Changes in Plasma Sodium [Time frame: baseline, every day up to 30 days]
- Changes in plasma osmolality [Time frame: baseline, every day up to 30 days]
- Changes in urine osmolality [Time frame: baseline, every day up to 30 days]
- Changes in urine volume [Time frame: baseline, every day up to 30 days]
Secondary outcome measures (10)
- Changes in body weight [Time frame: baseline, every day up to 30 days]
- Changes in total body water [Time frame: baseline, every day up to 30 days]
- Changes in intracellular volume [Time frame: baseline, every day up to 30 days]
- Changes in extracellular volume [Time frame: baseline, every day up to 30 days]
- Changes in blood pressure [Time frame: baseline, every day up to 30 days]
- Changes in cell size [Time frame: baseline, every day up to 30 days]
- Changes in intracellular electrolyte levels [Time frame: baseline, every day up to 30 days]
- Changes in copeptin levels [Time frame: baseline, every day up to 30 days]
- Changes in renin levels [Time frame: baseline, every day up to 30 days]
- Changes in aldosterone levels [Time frame: baseline, every day up to 30 days]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital of Cologne — Cologne
Identifiers
NCT: NCT05692726 · V1.0-20220315