NCT03703713

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

October 9, 2018

Last Update Submit

May 7, 2024

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

  • Colloid osmotic pressure

    Measurement of colloid osmotic pressure

    8 hours

Secondary Outcomes (2)

  • Body compartments

    8 hours.

  • Body compartments

    8 hours

Study Arms (1)

Hyponatremia

Patients treated for hyponatremia (\<125 mmol/L Sodium) in the intensive care department.

Drug: Sodium chloride

Interventions

Sodium chlorideDRUG

Treatment with Sodium chloride

Hyponatremia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients treated for Hyponatremia at the intensive care unit.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Vrinnevi Hospital

Norrköping, Sweden

Location

MeSH Terms

Conditions

Hyponatremia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assoc prof, consultant

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 12, 2018

Study Start

October 9, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

SE(1)