University Hospital of Cologne
Cologne, 50937, Germany
Location status: Recruiting
Location contact
Sadrija Cukoski
CONTACT
Sadrija Cukoski
SUB_INVESTIGATOR
Volker Burst, MD
CONTACT
Volker Burst, MD, Prof.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05692726
To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cologne, 50937, Germany
Location status: Recruiting
Sadrija Cukoski
CONTACT
Sadrija Cukoski
SUB_INVESTIGATOR
Volker Burst, MD
CONTACT
Volker Burst, MD, Prof.
PRINCIPAL_INVESTIGATOR
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge
Time frame: baseline, every day up to 30 days
Measurement of plasma sodium in blood samples
Time frame: baseline, every day up to 30 days
Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment
Time frame: baseline, every day up to 30 days
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality
Time frame: baseline, every day up to 30 days
Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume
Time frame: baseline, every day up to 30 days
Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement
Time frame: baseline, every day up to 30 days
Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement
Time frame: baseline, every day up to 30 days
Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
Time frame: baseline, every day up to 30 days
Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
Time frame: baseline, every day up to 30 days
Measurement of blood pressure before, during and after hyponatremia treatment
Time frame: baseline, every day up to 30 days
Determination of blood cell size via measurement of mean corpuscular volume
Time frame: baseline, every day up to 30 days
Measurement of whole blood samples via ICP-mass spectrometry
Time frame: baseline, every day up to 30 days
Measurement of copeptin in blood samples
Time frame: baseline, every day up to 30 days
Measurement of renin in blood samples
Time frame: baseline, every day up to 30 days
Measurement of aldosterone in blood samples
Contact information is provided by the study sponsor or research team.
Sadrija Cukoski
CONTACT
Volker Burst, MD, Prof
CONTACT
University of Cologne
Other
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
Acronym: EvenT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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