Euthyroid Sick SyndromePhase 4NCT01631305
Levothyroxine for Children With Euthyroid Sick Syndrome
A Phase 4 study testing Levothyroxine and Calcium magnesia in people with Euthyroid Sick Syndrome, run by Sinaloa Pediatric Hospital at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Euthyroid Sick Syndrome
- What is being tested?
- Levothyroxine and Calcium magnesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 4
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children aged 1 month to 17 years.
- Admitted to pediatric intensive care unit.
- TSH and thyroid hormones below age specific levels.
Who cannot join
- Known thyroid condition.
- Brain death.
- Gut conditions that contraindicate oral route.
- Readmissions to intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.
The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.
Read the detailed description
Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.
- Conditions
- Euthyroid Sick Syndrome
- Being tested
- Levothyroxine, Calcium magnesia
- Keywords
- Euthyroid Sick Syndromes, Thyroxine, Intensive care
- Medical subject headings
- Euthyroid Sick Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Brand: Eutirox.
3 mcg/kg/day
Calcium magnesiaOther
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | 3 mcg/kg/day Receives: Drug: Levothyroxine |
| Control | Placebo comparator | Calcium magnesia. Receives: Other: Calcium magnesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes (4)
Length of time in intensive care
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ventilation days
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Use of vasopressors
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Thyroid hormones levels
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Euthyroid Sick SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinaloa Pediatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Javier Martínez-García, Sinaloa Pediatric Hospital
- Investigators
- Jesus J Martinez, MD, Study chair, Sinaloa Pediatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631305
- Sponsor's protocol ID
- HPS-01
- Status last verified
- Mar 2014
- First submitted
- 26 Jun 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Levothyroxine in Critical Children With Euthyroid Sick Syndrome in a Pediatric Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01631305
- Acronym / sponsor ID
- HPS-01
- Conditions
- Euthyroid Sick Syndrome
- Keywords
- Euthyroid Sick Syndromes, Thyroxine, Intensive care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sinaloa Pediatric HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2012 (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.
The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.
Detailed description
Children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit, will be randomised to receive either Levothyroxine or placebo, to determine if it diminishes mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: Levothyroxine3 mcg/kg/day |
| Control | Placebo comparator | Other: Calcium magnesiaCalcium magnesia. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All children aged 1 month to 17 years.
- Admitted to pediatric intensive care unit.
- TSH and thyroid hormones below age specific levels.
Key exclusion criteria (4 listed)
- Known thyroid condition.
- Brain death.
- Gut conditions that contraindicate oral route.
- Readmissions to intensive care unit.
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 |
|---|---|---|
| LevothyroxineAlso: Brand: Eutirox.3 mcg/kg/day | Drug | Levothyroxine |
| Calcium magnesiaPlacebo. | Other | Control |
Primary outcome
All cause mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
4 secondary outcomes
Length of time in intensive care
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ventilation days
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Use of vasopressors
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Thyroid hormones levels
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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 5 Mar 2014.
- Sinaloa Pediatric HospitalLink provided by the sponsor.
Related trials for Euthyroid Sick Syndrome
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
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.
Jesus J Martinez, MD study chair
Sinaloa Pediatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine and Calcium magnesia in people with Euthyroid Sick Syndrome, run by Sinaloa Pediatric Hospital at 1 site in Mexico.
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 3 inclusion and 4 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 5 Mar 2014. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
All cause mortality (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks). 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 5 Mar 2014.