HypernatremiaPhase 2HYDRANCT03658850
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients
A Phase 2 study testing Hydrochlorothiazide 50Mg in people with Hypernatremia and Critical Illness, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia 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?
- Hydrochlorothiazide 50Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 10 Mar 2020
- Phase
- Phase 2
- 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
- hospitalized for intensive care,
- Over 18 years of age,
- Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
- Mean arterial pressure greater than 65mmHg
Who cannot join
- Absence of consent to participate in the study
- Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
- Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
- Unavailable enteral route.
- Use of hydrochlorothiazide in the last 7 days of ICU admission.
- History of allergy or intolerance to hydrochlorothiazide or other thiazides.
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- Nephrogenic Diabetes Insipidus.
- Renal impairment KDIGO 3
- Indication of renal replacement therapy.
- Acute neurological insult.
- Heart failure American Heart Association classification (AHA), class D.
- Liver cirrhosis Child-Pugh C.
- Pregnant women
- Exclusive palliative care
- Dying, with expected survival less than 48 hours
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo
André LN Gobatto, M.D., +5511991796501, andregobatto@gmail.com
André LN Gobatto, M.D.
About this study
Official title: Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
- Conditions
- Hypernatremia, Critical Illness
- Being tested
- Hydrochlorothiazide 50Mg, Placebos
- Keywords
- hypernatremia, Critical care
- 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.
Hydrochlorothiazide 50MgDrug
for the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3
PlacebosDrug
for the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days. Receives: Drug: Hydrochlorothiazide 50Mg |
| Control | Placebo comparator | placebo group will receive one tablet or equivalent volume of enteral solution of inert substance Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypernatremia correction
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
Measured: DAY 3
Secondary outcomes (5)
renal replacement therapy
need to renal replacement therapy
Measured: 6 months
mechanical ventilation
incidence of mechanical ventilation
Measured: 6 months
vasoactive drugs
need for vasoactive drugs
Measured: 6 months
mortality
hospital mortality
Measured: 6 months
serious adverse events
incidence of serious adverse events 37/5000 incidence of serious adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Oct 2018
- Primary completion10 Dec 2019 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Luiz Nunes Gobatto, University of Sao Paulo
- Investigators
- André LN Gobatto, p.h.d, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658850
- Sponsor's protocol ID
- 2.603.927
- Acronym
- HYDRA
- Status last verified
- Apr 2019
- First submitted
- 22 May 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03658850
- Acronym / sponsor ID
- HYDRA / 2.603.927
- Conditions
- Hypernatremia, Critical Illness
- Keywords
- hypernatremia, Critical care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 5 Sep 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.
HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Hydrochlorothiazide 50Mgthe experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days. |
| Control | Placebo comparator | Drug: Placebosplacebo group will receive one tablet or equivalent volume of enteral solution of inert substance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hospitalized for intensive care,
- Over 18 years of age,
- Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),
- Mean arterial pressure greater than 65mmHg
Key exclusion criteria (15 listed)
- Absence of consent to participate in the study
- Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate> 4mMol / L.
- Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.
- Unavailable enteral route.
- Use of hydrochlorothiazide in the last 7 days of ICU admission.
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 |
|---|---|---|
| Hydrochlorothiazide 50Mgfor the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3 | Drug | Intervention |
| Placebosfor the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3 | Drug | Control |
Primary outcome
hypernatremia correction
Time frame: DAY 3
proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3
5 secondary outcomes
renal replacement therapy
Time frame: 6 months
mechanical ventilation
Time frame: 6 months
vasoactive drugs
Time frame: 6 months
mortality
Time frame: 6 months
serious adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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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.
André LN Gobatto, p.h.d principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrochlorothiazide 50Mg in people with Hypernatremia and Critical Illness, run by University of Sao Paulo at 1 site in Brazil.
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 15 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 30 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 André LN Gobatto, p.h.d (+5571988646501, andregobatto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypernatremia correction (time frame: DAY 3). 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 30 Apr 2019.