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NCT03703713 Clinical Trial

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
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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