Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial

NCT ID: NCT05692726

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2026-09-30

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.

Conditions

Non-hypervolemic Hyponatremia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with non-hypervolemic hypotonic hyponatremia

Patients

Intervention Type: OTHER

Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge

Interventions

Patients

Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Volker Burst

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Volker Burst, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Locations

University Hospital of Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Volker Burst, MD, Prof

Role: CONTACT

volker.burst@uk-koeln.de

+49 221-478-97222

Sadrija Cukoski

Role: CONTACT

sadrija.cukoski@uk-koeln.de

Facility Contacts

Volker Burst, MD

Role: primary

volker.burst@uk-koeln.de

+49(0)221 478 97222

Sadrija Cukoski

Role: backup

sadrija.cukoski@uk-koeln.de

Other Identifiers

V1.0-20220315

Identifier Type: -

Identifier Source: org_study_id