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

NCT ID: NCT03093766

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-07

Study Completion Date

2018-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ICU-acquired Hypernatremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Predicted duration of ICU-admission \>48 hours

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christiaan Boerma

Role: PRINCIPAL_INVESTIGATOR

medical center leeuwarden

Locations

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Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 23336363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27703807 (View on PubMed)

Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7.

Reference Type BACKGROUND
PMID: 22404059 (View on PubMed)

Other Identifiers

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ZRTPO 996

Identifier Type: -

Identifier Source: org_study_id

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