Colloid Osmotic Pressure and Osmolality in Hyponatremia

Hyponatremia Clinical Trial

Official title:

Colloid Osmotic Pressure and Osmolality in Hyponatremia. Additional Diagnostic Aspects and Guide to Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03703713
• Other study ID #: COOH
• Status: Terminated
• Start date: October 9, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2024
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hyponatremia (serum sodium of less than 135 mmol/L)is a very common electrolyte disorder. The reasons for the disorder varies as well as if it is acute or chronic.

In this study we wish to follow changes in colloid osmotic pressure and osmolality during the initial treatment hours. We also wish to use mass balance for the calculation of body compartments and to detect fluid translocation between these.

Description:

Patients with hyponatremia arriving att the intensive care unit are asked to participate in the study. The first blood samples are collected before initializing the treatment as well as measurements of body compartments with a bioimpedance analyzer. Collected blood samples are electrolytes (Sodium, Potassium and Chloride), colloid osmotic pressure, osmolality and hemoglobin. These samples are repeated at 4 and 8 hours after start of the study. Amount of infused fluid as well as electrolytes are recorded. Urine volume is measured and urine samples are analyzed for the loss of electrolytes.

Additional samples for guidance of treatment are collected every hour.

Hopefully the addition of colloid osmotic pressure, osmolality and mass balance can be beneficial in the diagnosis of the reason for the disorder as well as for the treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated for Hyponatremia at the intensive care unit.

Exclusion Criteria:

• Circulatory instable patients in need of treatment for more than the hyponatremia.

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• Sodium chloride
Treatment with Sodium chloride

Locations

Country	Name	City	State
Sweden	Intensive Care Unit, Vrinnevi Hospital	Norrköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colloid osmotic pressure	Measurement of colloid osmotic pressure	8 hours
Secondary	Body compartments	Bioimpedance analysis is performed every 4 hours.	8 hours.
Secondary	Body compartments	Mass balance Sodium and Chloride	8 hours