HypernatremiaHYPNICNCT03752450
Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit
An observational study of Hypernatremia, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 May 2018to 10 Apr 2019
- 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: As a cardiothoracic and oncologic center, the ICU in the Catharina Hospital mostly admits postoperative patients. Other categories of admission are sepsis, respiratory insufficiency, intoxication. However, all patients with an indication for hemodynamic, respiratory of metabolic monitoring will be admitted. The Catharina Hospital is a tertiairy referral hospital. The ICU has 32 beds.
Who may be able to join
- Adults >17 years old
- Admitted >48 hours in ICU
Who cannot join
- Expected discharge same day as day of inclusion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: Insight in the Development and Recovery of Hypernatremia in Critically Ill Patients.
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.
Read the detailed description
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. The main mechanism is an imbalance between sodium and total body water. Consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. Previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk.
This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.
- Conditions
- Hypernatremia
- Keywords
- Water-electrolyte imbalance
- Medical subject headings
- Hypernatremia, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | All patients admitted to ICU >48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of hypernatremia
Serum sodium levels >145mmol/L
Measured: During ICU admission
Recovery of hypernatremia
Serum sodium levels returning back to levels below 146mmol/L
Measured: During ICU admission
Secondary outcomes (2)
Mortality
Patient did or did not pass away.
Measured: During ICU admission as well as during hospital admission
Length of stay
Number of days of admission
Measured: Admission in ICU as well as in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start25 May 2018
- Primary completion20 Dec 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eveline Mestrom, Catharina Ziekenhuis Eindhoven
- Investigators
- Eveline Mestrom, MD, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752450
- Sponsor's protocol ID
- HYPNIC
- Acronym
- HYPNIC
- Status last verified
- Apr 2019
- First submitted
- 21 Nov 2018
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.
Publications
Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
PubMed 23369520Lindner G, Funk GC, Lassnigg A, Mouhieddine M, Ahmad SA, Schwarz C, Hiesmayr M. Intensive care-acquired hypernatremia after major cardiothoracic surgery is associated with increased mortality. Intensive Care Med. 2010 Oct;36(10):1718-1723. doi: 10.1007/s00134-010-1968-4. Epub 2010 Jul 24.
PubMed 20658124Marshall DC, Salciccioli JD, Goodson RJ, Pimentel MA, Sun KY, Celi LA, Shalhoub J. The association between sodium fluctuations and mortality in surgical patients requiring intensive care. J Crit Care. 2017 Aug;40:63-68. doi: 10.1016/j.jcrc.2017.02.012. Epub 2017 Feb 13.
PubMed 28347943Bihari S, Festa M, Peake SL, Seppelt IM, Williams P, Wilkins B, Bersten A. Sodium administration in critically ill paediatric patients in Australia and New Zealand: a multicentre point prevalence study. Crit Care Resusc. 2014 Jun;16(2):112-8.
PubMed 24888281Stelfox HT, Ahmed SB, Zygun D, Khandwala F, Laupland K. Characterization of intensive care unit acquired hyponatremia and hypernatremia following cardiac surgery. Can J Anaesth. 2010 Jul;57(7):650-8. doi: 10.1007/s12630-010-9309-1. Epub 2010 Apr 20.
PubMed 20405264
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight in the Development and Recovery of Hypernatremia in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT03752450
- Acronym / sponsor ID
- HYPNIC / HYPNIC
- Conditions
- Hypernatremia
- Keywords
- Water-electrolyte imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 26 Nov 2018 (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.
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.
Detailed description
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. The main mechanism is an imbalance between sodium and total body water. Consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. Previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk.
This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | –All patients admitted to ICU >48 hours will be included. Eventually, a number of these patients will develop hypernatremia and form the cases. The patients who will not develop hypernatremia will be assigned as the controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As a cardiothoracic and oncologic center, the ICU in the Catharina Hospital mostly admits postoperative patients. Other categories of admission are sepsis, respiratory insufficiency, intoxication. However, all patients with an indication for hemodynamic, respiratory of metabolic monitoring will be admitted. The Catharina Hospital is a tertiairy referral hospital. The ICU has 32 beds.
Key inclusion criteria (2 listed)
- Adults >17 years old
- Admitted >48 hours in ICU
Key exclusion criteria (1 listed)
- Expected discharge same day as day of inclusion
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
Development of hypernatremia
Time frame: During ICU admission
Serum sodium levels >145mmol/L
Recovery of hypernatremia
Time frame: During ICU admission
Serum sodium levels returning back to levels below 146mmol/L
2 secondary outcomes
Mortality
Time frame: During ICU admission as well as during hospital admission
Length of stay
Time frame: Admission in ICU as well as in hospital
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 12 Apr 2019.
- Results publication: PubMed 23369520Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
- Results publication: PubMed 20658124Lindner G, Funk GC, Lassnigg A, Mouhieddine M, Ahmad SA, Schwarz C, Hiesmayr M. Intensive care-acquired hypernatremia after major cardiothoracic surgery is associated with increased mortality. Intensive Care Med. 2010 Oct;36(10):1718-1723. doi: 10.1007/s00134-010-1968-4. Epub 2010 Jul 24.
- Results publication: PubMed 28347943Marshall DC, Salciccioli JD, Goodson RJ, Pimentel MA, Sun KY, Celi LA, Shalhoub J. The association between sodium fluctuations and mortality in surgical patients requiring intensive care. J Crit Care. 2017 Aug;40:63-68. doi: 10.1016/j.jcrc.2017.02.012. Epub 2017 Feb 13.
- Results publication: PubMed 24888281Bihari S, Festa M, Peake SL, Seppelt IM, Williams P, Wilkins B, Bersten A. Sodium administration in critically ill paediatric patients in Australia and New Zealand: a multicentre point prevalence study. Crit Care Resusc. 2014 Jun;16(2):112-8.
- Results publication: PubMed 20405264Stelfox HT, Ahmed SB, Zygun D, Khandwala F, Laupland K. Characterization of intensive care unit acquired hyponatremia and hypernatremia following cardiac surgery. Can J Anaesth. 2010 Jul;57(7):650-8. doi: 10.1007/s12630-010-9309-1. Epub 2010 Apr 20.
- Individual participant dataSharing planned: Undecided. If necessary for publication, the data will be provided according to Good Clinical Practice in an anonymized and deidentified fashion.
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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.
Eveline Mestrom, MD principal investigator
Catharina Ziekenhuis Eindhoven
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, run by Catharina Ziekenhuis Eindhoven 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 2 inclusion and 1 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 12 Apr 2019. 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?
Development of hypernatremia (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 NCT03752450, which also lists 5 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 12 Apr 2019.