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Colloid Osmotic Pressure and Osmolality in Hyponatremia

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ClinicalTrials.gov Identifier: NCT03703713
Recruitment Status : Unknown
Verified October 2018 by Joachim Zdolsek, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Hyponatremia Drug: Sodium chloride

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colloid Osmotic Pressure and Osmolality in Hyponatremia. Additional Diagnostic Aspects and Guide to Treatment
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Hyponatremia
Patients treated for hyponatremia (<125 mmol/L Sodium) in the intensive care department.
 Drug: Sodium chloride
Treatment with Sodium chloride


Outcome Measures
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Primary Outcome Measures :
  1. Colloid osmotic pressure [ Time Frame: 8 hours ]
    Measurement of colloid osmotic pressure


Secondary Outcome Measures :
  1. Body compartments [ Time Frame: 8 hours. ]
    Bioimpedance analysis is performed every 4 hours.

  2. Body compartments [ Time Frame: 8 hours ]
    Mass balance Sodium and Chloride


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients treated for severe hyponatremia, at the intensive care unit.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703713


Contacts
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Contact: Joachim Zdolsek, MD, PhD +46101031821 joachim.zdolsek@regionostergotland.se
Contact: Robert Svensson, MD, Head of department +46101040000 robert.svensson@regionostergotland.se

Locations
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Sweden
Intensive Care Unit, Vrinnevi Hospital Recruiting
Norrköping, Sweden
Contact: Joachim Zdolsek, MD, PhD    +46 101031821    joachim.zdolsek@regionostergotland.se   
Contact: Robert Svensson, MD, Head of department    +46 101040000    robert.svensson@regionostergotland.se   
Sponsors and Collaborators
University Hospital, Linkoeping
More Information
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Responsible Party: Joachim Zdolsek, MD, PhD, Assoc prof, consultant, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03703713    
Other Study ID Numbers: COOH
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases