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

NCT05692726 | Recruiting

• 1 other identifier: V1.0-20220315
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Non-hypervolemic Hyponatremia

Keywords

Electrolyte-free water clearance; hyponatremia

Outcome Measures

Primary Outcomes (4)

• Changes in Plasma Sodium

  Measurement of plasma sodium in blood samples

  baseline, every day up to 30 days

• Changes in plasma osmolality

  Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment

  baseline, every day up to 30 days

• Changes in urine osmolality

  Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality

  baseline, every day up to 30 days

• Changes in urine volume

  Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume

  baseline, every day up to 30 days

Secondary Outcomes (10)

• Changes in body weight

  baseline, every day up to 30 days

• Changes in total body water

  baseline, every day up to 30 days

• Changes in intracellular volume

  baseline, every day up to 30 days

• Changes in extracellular volume

  baseline, every day up to 30 days

• Changes in blood pressure

  baseline, every day up to 30 days

Study Arms (1)

Patients

Patients with non-hypervolemic hypotonic hyponatremia

Other: Patients

Interventions

Patients OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-hypervolemic hyponatremia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Volker Burst, MD, Prof.

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volker Burst, MD, Prof

CONTACT

+49 221-478-97222; volker.burst@uk-koeln.de

Sadrija Cukoski

CONTACT

sadrija.cukoski@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: October 15, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)