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CompletedNCT03093766BIASUpdated Jul 18, 2018

Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)

An observational study in ICU-acquired Hypernatremia, sponsored by Medical Centre Leeuwarden. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Medical Centre Leeuwarden · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
155
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this study is to find differences between patients who do and do not develop ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be performed. Also a couple of other factors that possibly contribute to the development of IAH and/or could give clues about the mechanisms in the development of IAH will be investigated.

Read the detailed description

ICU-acquired hypernatremia (IAH) is common in critically ill patients, but it's aetiology is still not fully understood. Sodium overload and inadequate fluid administration are generally considered important factors, but a previous retrospective study did not reveal differences in sodium or fluid balances between patients who did and did not develop IAH. Because this was retrospective these balances will be prospectively studied in this study to be more sure about the importances of these balances in the development of IAH. Previous studies indicated that (a lot) more factors contribute to the development of IAH. In this study these factors will be investigated, hoping to find differences between patients who do and do not develop IAH.

02

Conditions studied

  • ICU-acquired Hypernatremia

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Keywords

  • Aetiology
03

In context

Hypernatremia

49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.

This study's enrollment of 155 is below the median of 200 across 12 observational studies indexed under Hypernatremia.

Browse Hypernatremia studies →

Lead sponsor

Medical Centre Leeuwarden is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All unplanned ICU-admissions

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Predicted duration of ICU-admission >48 hours

Exclusion criteria

Exclusion Criteria:

  • Renal replacement therapy
  • Reason for admission necessitates actively elevation of serum sodium concentration
  • Electrolyte disturbance as reason for admission
  • ICU re-admission within 30 days
  • Referral from another ICU
  • Serum sodium concentration on admission 143mmol/l or above
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
155 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Sodium balance

    Differences in sodium balances between patients who do and do not develop IAH

    Time frame: During ICU-admission

  2. Fluid balance

    Differences in fluid balances between patients who do and do not develop IAH

    Time frame: During ICU-admission

Secondary outcomes

  1. Kidney function

    Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH

    Time frame: During ICU-admission

  2. Inflammation

    Differences in inflammation (CRP, infections) between patients who do and do not develop IAH

    Time frame: During ICU-admission

  3. Nutritional state

    Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH

    Time frame: During ICU-admission

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Study locations

1 site
  • Medisch Centrum Leeuwarden
    Leeuwarden, Netherlands
08

References and documents

Publications

  • Darmon M, Diconne E, Souweine B, Ruckly S, Adrie C, Azoulay E, Clec'h C, Garrouste-Orgeas M, Schwebel C, Goldgran-Toledano D, Khallel H, Dumenil AS, Jamali S, Cheval C, Allaouchiche B, Zeni F, Timsit JF. Prognostic consequences of borderline dysnatremia: pay attention to minimal serum sodium change. Crit Care. 2013 Jan 21;17(1):R12. doi: 10.1186/cc11937. PubMed 23336363 ↗
  • van IJzendoorn MC, Buter H, Kingma WP, Navis GJ, Boerma EC. The Development of Intensive Care Unit Acquired Hypernatremia Is Not Explained by Sodium Overload or Water Deficit: A Retrospective Cohort Study on Water Balance and Sodium Handling. Crit Care Res Pract. 2016;2016:9571583. doi: 10.1155/2016/9571583. Epub 2016 Sep 14. PubMed 27703807 ↗
  • Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7. PubMed 22404059 ↗

Individual participant data

Plan to share: Undecided — Collected data will be available through an online portal / storage website as soon as the manuscript was published. From that moment data can be obtained after a request via the online portal / storage website.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Apr 2018, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2017
First posted
Mar 28, 2017
StartActual
Aug 7, 2017
Primary completionActual
Apr 16, 2018
CompletionActual
Jun 1, 2018
Last update
Jul 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03093766
Lead sponsor
Medical Centre Leeuwarden
Collaborators
University Medical Center Groningen
Responsible party
Sponsor
First posted
Mar 28, 2017
Start date
Aug 7, 2017
Primary completion
Apr 16, 2018
Completion
Jun 1, 2018
Last update
Jul 18, 2018

Study contacts

Christiaan Boerma
principal investigator · medical center leeuwarden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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