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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cologne

About this trial

To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with non-hypervolemic hyponatremia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patients

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

Changes in Plasma Sodium

Measurement of plasma sodium in blood samples

Time frame
baseline, every day up to 30 days
2

Changes in plasma osmolality

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
3

Changes in urine osmolality

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
4

Changes in urine volume

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

Secondary outcomes

1

Changes in body weight

Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement

Time frame
baseline, every day up to 30 days
2

Changes in total body water

Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement

Time frame
baseline, every day up to 30 days
3

Changes in intracellular volume

Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement

Time frame
baseline, every day up to 30 days
4

Changes in extracellular volume

Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement

Time frame
baseline, every day up to 30 days

Other outcomes

Sponsors and contacts

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