Colloid Osmotic Pressure and Osmolality in Hyponatremia

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyponatremia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Joachim Zdolsek, MD, PhD; Phone Number: +46101031821; Email: joachim.zdolsek@regionostergotland.se
• Study Contact Backup: Name: Robert Svensson, MD, Head of department; Phone Number: +46101040000; Email: robert.svensson@regionostergotland.se

Study Locations

• Sweden
  • Norrköping, Sweden
    • Recruiting
    • Intensive Care Unit, Vrinnevi Hospital
    • Contact: Joachim Zdolsek, MD, PhD; Phone Number: +46 101031821; Email: joachim.zdolsek@regionostergotland.se
    • Contact: Robert Svensson, MD, Head of department; Phone Number: +46 101040000; Email: robert.svensson@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated for severe hyponatremia, at the intensive care unit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colloid osmotic pressure	Measurement of colloid osmotic pressure	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body compartments	Bioimpedance analysis is performed every 4 hours.	8 hours.
Body compartments	Mass balance Sodium and Chloride	8 hours

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: COOH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No