HypernatraemiaNCT01974739
Hydrochloorthiazide and Hypernatriaemie
A study testing Hydrochloorthiazide in people with Hypernatraemia, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce hypernatremia and shorten the time of hypernatremia, we investigate the effect of hydrochloorthiazide compared to a placebo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatraemia
- What is being tested?
- Hydrochloorthiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to May 2015
- Phase
- Interventional
- 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
Who may be able to join
- sodium > 142
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8801 AD
About this study
Official title: Hypernatraemia and Diuretics in Intensive Care Patients
Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce hypernatremia and shorten the time of hypernatremia, we investigate the effect of hydrochloorthiazide compared to a placebo
- Conditions
- Hypernatraemia
- Being tested
- Hydrochloorthiazide, placebo
- Keywords
- intensive care, diuretics
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochloorthiazideDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| hydrochloorthiazide | Active comparator | once a day 25 mg Receives: Drug: Hydrochloorthiazide |
| placebo | Placebo comparator | once a day placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium level
a decrease of 5 mmol/L sodium in plama
Measured: 7 days
Secondary outcomes (1)
time hypernatraemia
decrease of duration high sodium level in plasma
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypernatraemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- Christiaan Boerma, MD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974739
- Sponsor's protocol ID
- ABR 44878
- Status last verified
- Jun 2015
- First submitted
- 28 Oct 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypernatraemia and Diuretics in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01974739
- Acronym / sponsor ID
- ABR 44878
- Conditions
- Hypernatraemia
- Keywords
- intensive care, diuretics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
Acquired hypernatremia appears to be associated with mortallity in ICU. To reduce hypernatremia and shorten the time of hypernatremia, we investigate the effect of hydrochloorthiazide compared to a placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrochloorthiazide | Active comparator | Drug: Hydrochloorthiazideonce a day 25 mg |
| placebo | Placebo comparator | Drug: placeboonce a day placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sodium > 142
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| Hydrochloorthiazide | Drug | hydrochloorthiazide |
| placebo | Drug | placebo |
Primary outcome
sodium level
Time frame: 7 days
a decrease of 5 mmol/L sodium in plama
1 secondary outcome
time hypernatraemia
Time frame: 7 days
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 23 Jun 2015.
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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.
Christiaan Boerma, MD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrochloorthiazide in people with Hypernatraemia, 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 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 23 Jun 2015. 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. Some participants in this study may receive a placebo. 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 level (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2015.