HypernatremiaNCT06037928
Plasma Sodium and Sodium Administration in the ICU
An observational study of Hypernatremia and Hyponatremia, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Patients in the Intensive Care Unit often present with low levels of plasma sodium and are therefore often administered high amounts of sodium, both as an additive to intravenous glucose solutions and as a constituent of various drugs and infusion fluids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia, Hyponatremia, Critical Illness
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2023to 31 Jan 2024
- 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: Critically ill patients with a documented length of stay at the Intensive Care Unit of seven days minimum
Who may be able to join
- Adult
- Documented length of stay at the Central Intensive Care Unit (CIVA) at the University Hospital of Linköping of seven (7) days minimum.
- The patient has been discharged from the ICU.
- Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission.
Who cannot join
- The patient has previously been included in the study in connection with another ICU-admission.
- The patient has a severe hyponatremia (<129 mmol/L) upon arrival to the ICU.
- The patient has a severe hypernatremia (>149 mmol/L) upon arrival to the ICU.
- The patient is severely hyperosmolar (>330 mmol/L) upon arrival to the ICU.
- The patient is severely hyperglycemic (>30 mmol/L) upon arrival to the ICU.
- The patient has an elevated serum urea (>30 mmol/L) upon arrival to the ICU.
Show all 9Show fewer
- The patient receives any dialysis treatment during the observation time.
- The patient is suspected to have an elevated intracranial pressure during the observation time or is suspected to have other intracranial pathology that is likely to affect sodium homeostasis
- The patient has an intoxication with toxic alcohols as a primary diagnosis.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
University Hospital Linköping
Linköping, 58185
Joel Landström, +46725165345, joela037@student.liu.se
About this study
Official title: Plasma Sodium and Sodium Administration in the ICU. A Retrospective Observational Study.
Patients in the Intensive Care Unit often present with low levels of plasma sodium and are therefore often administered high amounts of sodium, both as an additive to intravenous glucose solutions and as a constituent of various drugs and infusion fluids. Recent findings question the benefit of these large quantities of sodium and raise the question whether the individual physician takes the total sodium administration into account when sodium additives are prescribed. It can also be suspected that sodium prescription differs significantly between physicians.
Read the detailed description
Treatment with intravenous fluids (fluid therapy) is a cornerstone in intensive care. The primary aim of fluid therapy is to optimize the amount of fluid in the various spaces of the body: intravascularly (plasma), intracellularly and interstitially. Secondarily, one tries to optimize the constitution of fluid in plasma, since this is the only fluid space that is available for analysis. Fluid constitution is referring to the physical properties such as pH-value, osmolality, and partly the concentration of different elements solved in plasma (i.e. sodium, potassium, chloride, magnesium, and proteins like albumin). For this reason, there are a lot of different fluids that the physician in the intensive care can choose from. In addition, the physician can also choose to prescribe different additives to adapt these fluids to fulfil the individual patient's needs. Therefore, to prescribe both the amount and constituency of fluid therapy is a key task for ICU-physicians.
One of the most important additives to be prescribed is sodium. Sodium is the molecule (except for water) that has the highest concentration in plasma (normally around 140 mmol/L) and is therefore of utmost importance for plasma osmolality. Sodium concentration in plasma is often decreased in critically ill patients (hyponatremia) which, in turn, is associated with a worse outcome, and thus a normal task for an ICU-physician to attempt to regulate through administering amounts of sodium that are substantially higher than the physiological needs.
Recent findings have revealed that there is a large variation between different physicians when it comes to the amount of fluid the patient receives, a variation that has no scientific basis.
Fluids used in the operating room and in the intensive care often contain large quantities of sodium to create a physiological osmolality. It is thus hypothesized that it is not only the large quantities of fluid that causes a worse outcome in fluid overload, but also the un-physiologically large amount of administered sodium.
The aim of the study is partly to gain knowledge about how sodium prescription is performed in clinical practice in the intensive care, as well as how this administration relates to actual changes in plasma sodium.
Statistical method: Normal distribution will be tested via the Shapiro-Wilks test. All tests of significance are performed two-sided. P-value lower than 0.05 is considered significant. No corrections for multiple comparisons are performed if nothing else is stated.
Missing values: Single missing values are principally not replaced. In exceptional cases, if missing data leads to a whole series of data being misleading, then missing data can be imputed by calculating the mean of two adjacent values, under the condition that this results in a reasonable value.
- Conditions
- Hypernatremia, Hyponatremia, Critical Illness
- Keywords
- Fluid Therapy, ICU, Drug Prescription
- Medical subject headings
- Hypernatremia, Hyponatremia, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other routes.
The amount of sodium additive is defined as the amount of sodium in mmol/kg ABW (actual body weight) that is being given in glucose solutions during the coming 24 hours.
Example: A patient weighing 70 kilograms is being prescribed intravenous glucose of 1L, with an additive of 40 mmol of sodium during 12 hours. The amount of additive will then be calculated as (40+40)×2⁄70=2.3 mmol/kg
The amount of expected sodium administrated, per kg and day, is defined as the sodium contents of:
- Enteral and/or parenteral nutrition during one day.
- Drugs administered through infusion pumps during one day.
- Other fluids that have been prescribed during the morning round.
Measured: During admission to ICU for a maximum of 28 days
Secondary outcomes (6)
The coefficient of determination (r2) in a multivariate analysis where prescribing physician is the independent variable and the amount of prescribed sodium additive is the dependent variable.
Only data points where administering physician has been registered and where plasma sodium is < 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. The amount of sodium additive is defined as the amount of sodium in mmol/kg ABW that is prescribed through glucose infusion the coming day.
Measured: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between anesthesiologists mainly working in intensive care, anesthesiologists mainly working with patients undergoing surgery and between resident physicians.
Only data points where administering physician has been registered and where plasma sodium is < 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. Information regarding chief working area will be retrieved through the schedule of the clinic.
Measured: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between physicians born no later than 12-31-1982 and physicians born 1983 and later.
Only data points where administering physician has been registered and where plasma sodium is < 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium. Information regarding birth year is retrieved through an official database (www.mrkoll.se).
Measured: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between plasma sodium and the amount of prescribed sodium additive.
Only data points where plasma sodium is < 150 mmol/L are included. Data will, however, be displayed for all levels of plasma sodium.
Measured: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the amount of prescribed sodium additive and observed changes in plasma sodium.
Calculated in intervals of 1, 2, 3, 4 and 5 days
Measured: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the total amount of administered sodium and observed changes in plasma sodium.
Calculated in intervals of 1, 2, 3, 4 and 5 days
Measured: During admission to ICU for a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start4 Sep 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
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 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Bahlmann, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037928
- Sponsor's protocol ID
- IVA-salt
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Carvalho H, Letellier T, Karakachoff M, Desvaux G, Caillon H, Papuchon E, Bentoumi-Loaec M, Benaouicha N, Canet E, Chapelet G, Le Turnier P, Montassier E, Rouhani A, Goffinet N, Figueres L. Hyponatremia is associated with poor outcome in COVID-19. J Nephrol. 2021 Aug;34(4):991-998. doi: 10.1007/s40620-021-01036-8. Epub 2021 Apr 7.
PubMed 33826113Lilot M, Ehrenfeld JM, Lee C, Harrington B, Cannesson M, Rinehart J. Variability in practice and factors predictive of total crystalloid administration during abdominal surgery: retrospective two-centre analysis. Br J Anaesth. 2015 May;114(5):767-76. doi: 10.1093/bja/aeu452. Epub 2015 Jan 13.
PubMed 25586725Van Regenmortel N, Moers L, Langer T, Roelant E, De Weerdt T, Caironi P, Malbrain MLNG, Elbers P, Van den Wyngaert T, Jorens PG. Fluid-induced harm in the hospital: look beyond volume and start considering sodium. From physiology towards recommendations for daily practice in hospitalized adults. Ann Intensive Care. 2021 May 17;11(1):79. doi: 10.1186/s13613-021-00851-3.
PubMed 33999276
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Sodium and Sodium Administration in the ICU. A Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT06037928
- Acronym / sponsor ID
- IVA-salt
- Conditions
- Hypernatremia, Hyponatremia, Critical Illness
- Keywords
- Fluid Therapy, ICU, Drug Prescription
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 14 Sep 2023 (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.
Patients in the Intensive Care Unit often present with low levels of plasma sodium and are therefore often administered high amounts of sodium, both as an additive to intravenous glucose solutions and as a constituent of various drugs and infusion fluids. Recent findings question the benefit of these large quantities of sodium and raise the question whether the individual physician takes the total sodium administration into account when sodium additives are prescribed. It can also be suspected that sodium prescription differs significantly between physicians.
Detailed description
Treatment with intravenous fluids (fluid therapy) is a cornerstone in intensive care. The primary aim of fluid therapy is to optimize the amount of fluid in the various spaces of the body: intravascularly (plasma), intracellularly and interstitially. Secondarily, one tries to optimize the constitution of fluid in plasma, since this is the only fluid space that is available for analysis. Fluid constitution is referring to the physical properties such as pH-value, osmolality, and partly the concentration of different elements solved in plasma (i.e. sodium, potassium, chloride, magnesium, and proteins like albumin). For this reason, there are a lot of different fluids that the physician in the intensive care can choose from. In addition, the physician can also choose to prescribe different additives to adapt these fluids to fulfil the individual patient's needs. Therefore, to prescribe both the amount and constituency of fluid therapy is a key task for ICU-physicians.
One of the most important additives to be prescribed is sodium. Sodium is the molecule (except for water) that has the highest concentration in plasma (normally around 140 mmol/L) and is therefore of utmost importance for plasma osmolality. Sodium concentration in plasma is often decreased in critically ill patients (hyponatremia) which, in turn, is associated with a worse outcome, and thus a normal task for an ICU-physician to attempt to regulate through administering amounts of sodium that are substantially higher than the physiological needs.
Recent findings have revealed that there is a large variation between different physicians when it comes to the amount of fluid the patient receives, a variation that has no scientific basis.
Fluids used in the operating room and in the intensive care often contain large quantities of sodium to create a physiological osmolality. It is thus hypothesized that it is not only the large quantities of fluid that causes a worse outcome in fluid overload, but also the un-physiologically large amount of administered sodium.
The aim of the study is partly to gain knowledge about how sodium prescription is performed in clinical practice in the intensive care, as well as how this administration relates to actual changes in plasma sodium.
Statistical method: Normal distribution will be tested via the Shapiro-Wilks test. All tests of significance are performed two-sided. P-value lower than 0.05 is considered significant. No corrections for multiple comparisons are performed if nothing else is stated.
Missing values: Single missing values are principally not replaced. In exceptional cases, if missing data leads to a whole series of data being misleading, then missing data can be imputed by calculating the mean of two adjacent values, under the condition that this results in a reasonable value.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with a documented length of stay at the Intensive Care Unit of seven days minimum
Key inclusion criteria (4 listed)
- Adult
- Documented length of stay at the Central Intensive Care Unit (CIVA) at the University Hospital of Linköping of seven (7) days minimum.
- The patient has been discharged from the ICU.
- Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission.
Key exclusion criteria (9 listed)
- The patient has previously been included in the study in connection with another ICU-admission.
- The patient has a severe hyponatremia (<129 mmol/L) upon arrival to the ICU.
- The patient has a severe hypernatremia (>149 mmol/L) upon arrival to the ICU.
- The patient is severely hyperosmolar (>330 mmol/L) upon arrival to the ICU.
- The patient is severely hyperglycemic (>30 mmol/L) upon arrival to the 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
The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other routes.
Time frame: During admission to ICU for a maximum of 28 days
The amount of sodium additive is defined as the amount of sodium in mmol/kg ABW (actual body weight) that is being given in glucose solutions during the coming 24 hours. Example: A patient weighing 70 kilograms is being prescribed intravenous glucose of 1L, with an additive of 40 mmol of sodium during 12 hours. The amount of additive will then be calculated as (40+40)×2⁄70=2.3 mmol/kg The amount of expected sodium administrated, per kg and day, is defined as the sodium contents of: 1. Enteral and/or parenteral nutrition during one day. 2. Drugs administered through infusion pumps during one day. 3. Other fluids that have been prescribed during the morning round.
6 secondary outcomes
The coefficient of determination (r2) in a multivariate analysis where prescribing physician is the independent variable and the amount of prescribed sodium additive is the dependent variable.
Time frame: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between anesthesiologists mainly working in intensive care, anesthesiologists mainly working with patients undergoing surgery and between resident physicians.
Time frame: During admission to ICU for a maximum of 28 days
Difference in median or mean in the amount of prescribed sodium additive between physicians born no later than 12-31-1982 and physicians born 1983 and later.
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between plasma sodium and the amount of prescribed sodium additive.
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the amount of prescribed sodium additive and observed changes in plasma sodium.
Time frame: During admission to ICU for a maximum of 28 days
The coefficient of determination (r2) between the total amount of administered sodium and observed changes in plasma sodium.
Time frame: During admission to ICU for a maximum of 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 33826113De Carvalho H, Letellier T, Karakachoff M, Desvaux G, Caillon H, Papuchon E, Bentoumi-Loaec M, Benaouicha N, Canet E, Chapelet G, Le Turnier P, Montassier E, Rouhani A, Goffinet N, Figueres L. Hyponatremia is associated with poor outcome in COVID-19. J Nephrol. 2021 Aug;34(4):991-998. doi: 10.1007/s40620-021-01036-8. Epub 2021 Apr 7.
- Background: PubMed 25586725Lilot M, Ehrenfeld JM, Lee C, Harrington B, Cannesson M, Rinehart J. Variability in practice and factors predictive of total crystalloid administration during abdominal surgery: retrospective two-centre analysis. Br J Anaesth. 2015 May;114(5):767-76. doi: 10.1093/bja/aeu452. Epub 2015 Jan 13.
- Background: PubMed 33999276Van Regenmortel N, Moers L, Langer T, Roelant E, De Weerdt T, Caironi P, Malbrain MLNG, Elbers P, Van den Wyngaert T, Jorens PG. Fluid-induced harm in the hospital: look beyond volume and start considering sodium. From physiology towards recommendations for daily practice in hospitalized adults. Ann Intensive Care. 2021 May 17;11(1):79. doi: 10.1186/s13613-021-00851-3.
- Individual participant dataSharing planned: No
Related trials for Hypernatremia
RecruitingPhase 2
Rapid Rehydration for Severe Hypernatremia
Hypernatremia
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruiting
Can Changes in Dialysate Sodium Concentration Improve Blood Pressure and Endothelial Function in Chronic HD Patients?
Dialysis Dependent Chronic Kidney Disease, Dialysis Patients
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.
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 Hypernatremia and Hyponatremia, run by University Hospital, Linkoeping at 1 site in Sweden.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Bahlmann, MD, PhD (+46739312281, hans.bahlmann@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other routes. (time frame: During admission to ICU for a maximum of 28 days). 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 NCT06037928, 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 26 Sep 2023.