ICU-acquired HypernatremiaBIASNCT03093766
Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)
An observational study of ICU-acquired Hypernatremia, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU-acquired Hypernatremia
- How many people
- 155 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Aug 2017to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All unplanned ICU-admissions
Who may be able to join
- Predicted duration of ICU-admission >48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Balance Study on ICU-acquired Hypernatremia and Sodium Handling
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.
- Conditions
- ICU-acquired Hypernatremia
- Keywords
- Aetiology
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium balance
Differences in sodium balances between patients who do and do not develop IAH
Measured: During ICU-admission
Fluid balance
Differences in fluid balances between patients who do and do not develop IAH
Measured: During ICU-admission
Secondary outcomes (3)
Kidney function
Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH
Measured: During ICU-admission
Inflammation
Differences in inflammation (CRP, infections) between patients who do and do not develop IAH
Measured: During ICU-admission
Nutritional state
Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH
Measured: During ICU-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start7 Aug 2017
- Primary completion16 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ICU-acquired HypernatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Christiaan Boerma, Principal investigator, medical center leeuwarden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093766
- Sponsor's protocol ID
- ZRTPO 996
- Acronym
- BIAS
- Status last verified
- May 2017
- First submitted
- 22 Mar 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 23336363van 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 27703807Bihari 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Study on ICU-acquired Hypernatremia and Sodium Handling
- ClinicalTrials.gov ID
- NCT03093766
- Acronym / sponsor ID
- BIAS / ZRTPO 996
- Conditions
- ICU-acquired Hypernatremia
- Keywords
- Aetiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All unplanned ICU-admissions
Key inclusion criteria (1 listed)
- Predicted duration of ICU-admission >48 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sodium balance
Time frame: During ICU-admission
Differences in sodium balances between patients who do and do not develop IAH
Fluid balance
Time frame: During ICU-admission
Differences in fluid balances between patients who do and do not develop IAH
3 secondary outcomes
Kidney function
Time frame: During ICU-admission
Inflammation
Time frame: During ICU-admission
Nutritional state
Time frame: During ICU-admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 23336363Darmon 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.
- Background: PubMed 27703807van 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.
- Background: PubMed 22404059Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiaan Boerma principal investigator
medical center leeuwarden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU-acquired Hypernatremia, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium balance (time frame: During ICU-admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093766, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.