HypernatremiaHYPNIC IINCT05085223
Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients
An observational study of Hypernatremia and Critical Illness, 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, Critical Illness
- What is being tested?
- Daily urine collection for biochemical analysis and Subanalysis for comparison of 24hour urine collection versus spot-check measurements
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2021to 30 Nov 2022
- 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 patients admitted to the Intensive Care Unit.
Who may be able to join
- Admitted to Intensive Care Unit
- Age 18 years or older
Who cannot join
- Age 17 years or younger
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623 EJ
Eveline Mestrom, MD, 0031402399500, eveline.mestrom@catharinaziekenhuis.nl
Ashley de Bie, MD, PhD, 0031402399500, ashley.d.bie@catharinaziekenhuis.nl
About this study
Official title: Development of Hypernatremia in Critically Ill Patients: Prospective Analysis
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 sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.
This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.
- Conditions
- Hypernatremia, Critical Illness
- Being tested
- Daily urine collection for biochemical analysis, Subanalysis for comparison of 24hour urine collection versus spot-check measurements
- Medical subject headings
- Hypernatremia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily urine collection for biochemical analysisOther
For every patient in ICU, a daily morning urine sample will be collected from the already collected urine via catheter.
Subanalysis for comparison of 24hour urine collection versus spot-check measurementsOther
For a subgroup of 30 sedated patients, 24 hour urine collection will be collected. In addition, every 2 hours a 10ml urine sample will be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypernatremia
After one year of collecting data on fluid and sodium balances, the patients who developed hypernatremia during their admission in the Intensive Care Unit will be compared to the patients who remained normonatremic throughout their ICU admission.
Measured: During admission in ICU
Secondary outcomes (1)
24 hour urine replacement for spot-checks
Assessing whether 24 hour urine collection can be replaced by spot-check measurements of urine by comparing both 24 hour urine and 2 hourly urine samples
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study startOct 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eveline Mestrom, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085223
- Sponsor's protocol ID
- HYPNIC II
- Acronym
- HYPNIC II
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mestrom EHJ, van der Stam JA, Te Pas ME, van der Hoeven JG, van Riel NAW, Bindels AJGH, Boer A, Scharnhorst V. Increased sodium intake and decreased sodium excretion in ICU-acquired hypernatremia: A prospective cohort study. J Crit Care. 2021 Jun;63:68-75. doi: 10.1016/j.jcrc.2021.02.002. Epub 2021 Feb 10.
PubMed 33621892
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Hypernatremia in Critically Ill Patients: Prospective Analysis
- ClinicalTrials.gov ID
- NCT05085223
- Acronym / sponsor ID
- HYPNIC II / HYPNIC II
- Conditions
- Hypernatremia, Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 20 Oct 2021 (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 sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.
This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.
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 patients admitted to the Intensive Care Unit.
Key inclusion criteria (2 listed)
- Admitted to Intensive Care Unit
- Age 18 years or older
Key exclusion criteria (1 listed)
- Age 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily urine collection for biochemical analysisFor every patient in ICU, a daily morning urine sample will be collected from the already collected urine via catheter. | Other | – |
| Subanalysis for comparison of 24hour urine collection versus spot-check measurementsFor a subgroup of 30 sedated patients, 24 hour urine collection will be collected. In addition, every 2 hours a 10ml urine sample will be collected. | Other | – |
Primary outcome
Hypernatremia
Time frame: During admission in ICU
After one year of collecting data on fluid and sodium balances, the patients who developed hypernatremia during their admission in the Intensive Care Unit will be compared to the patients who remained normonatremic throughout their ICU admission.
1 secondary outcome
24 hour urine replacement for spot-checks
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Background: PubMed 33621892Mestrom EHJ, van der Stam JA, Te Pas ME, van der Hoeven JG, van Riel NAW, Bindels AJGH, Boer A, Scharnhorst V. Increased sodium intake and decreased sodium excretion in ICU-acquired hypernatremia: A prospective cohort study. J Crit Care. 2021 Jun;63:68-75. doi: 10.1016/j.jcrc.2021.02.002. Epub 2021 Feb 10.
- Individual participant dataSharing planned: Undecided
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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.
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 Critical Illness, 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: status not confirmed, as of the sponsor's last update on 27 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eveline Mestrom, MD (0031402399500, eveline.mestrom@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypernatremia (time frame: During admission in ICU). 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 NCT05085223, which also lists 1 linked publication.
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 27 Oct 2021.