Brain Dead Organ DonorsPhase 4ECHOT4NCT02211053
Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controled Trial
A Phase 4 study testing Levothyroxine in people with Brain Dead Organ Donors, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Dead Organ Donors
- What is being tested?
- Levothyroxine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Dec 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prior signed written informed from family member (no more needed following amendment in July 2016)
- 16 years of age or older
- Brain death diagnosis
- Left ventricular ejection fraction < 50% determined by transthoracic echocardiography or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min + vasopressin
Who cannot join
- Heart failure history (removed after june 2015)
- Chronic exogenous oral T4 or T3 before death (removed after june 2015)
- Having received T4 infusion before recruitment(removed after june 2015)
- Echographic images not interpretable
- Age 75 and older(removed after june 2015)
- Prior coronary heart disease defined as prior coronary artery bypass graft or percutaneous coronary intervention (with or without stents)(removed after june 2015)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial
The primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors
- Conditions
- Brain Dead Organ Donors
- Being tested
- Levothyroxine, placebo
- Keywords
- Organ donation, Brain dead, Levothyroxine
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Synthroid(R)
20 mg IV bolus + 10 mg/h infusion
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Active comparator | Levothyroxine infusion 20 mg IV bolus then 10 mg/h infusion Receives: Drug: Levothyroxine |
| Placebo | Placebo comparator | Infusion matched to intervention arm Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility
- proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
Measured: In 2 years
Variation in left ventricular ejection fraction
Measured: 6 hours post infusion
Secondary outcomes (3)
Numbers of donated hearts
Measured: On organ donation surgery
Incidence of de novo atrial fibrillation
Measured: From beginning of infusion until beginning of retrieval surgery
Time from recruitment to the administration of the study drug
Measured: From randomization to 12 hours post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Recruitment was too slow and we cannot anticipate to recruit the target sample size
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 Brain Dead Organ DonorsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Julie Frenette, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Anne Julie Frenette, M.Sc, Principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211053
- Sponsor's protocol ID
- 2014-987
- Acronym
- ECHOT4
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Frenette AJ, Williamson D, Williams V, Lagace AM, Charbonney E, Serri K. A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors. Prog Transplant. 2019 Sep;29(3):261-268. doi: 10.1177/1526924819855083. Epub 2019 Jun 9.
PubMed 31179831
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Levothyroxine in Brain Death Organ Donors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02211053
- Acronym / sponsor ID
- ECHOT4 / 2014-987
- Conditions
- Brain Dead Organ Donors
- Keywords
- Organ donation, Brain dead, Levothyroxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was too slow and we cannot anticipate to recruit the target sample size
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Aug 2014 (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 primary objective of this study is to evaluate the feasibility of a randomized controlled trial comparing levothyroxine to placebo in neurologically deceased donors
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Active comparator | Drug: LevothyroxineLevothyroxine infusion 20 mg IV bolus then 10 mg/h infusion |
| Placebo | Placebo comparator | Drug: placeboInfusion matched to intervention arm |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Prior signed written informed from family member (no more needed following amendment in July 2016)
- 16 years of age or older
- Brain death diagnosis
- Left ventricular ejection fraction < 50% determined by transthoracic echocardiography or hemodynamic instability defined as a mean dose of noradrenaline 0.1 mcg/kg/min + vasopressin
Key exclusion criteria (6 listed)
- Heart failure history (removed after june 2015)
- Chronic exogenous oral T4 or T3 before death (removed after june 2015)
- Having received T4 infusion before recruitment(removed after june 2015)
- Echographic images not interpretable
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: Synthroid(R)20 mg IV bolus + 10 mg/h infusion | Drug | Levothyroxine |
| placebo | Drug | Placebo |
Primary outcome
Study feasibility
Time frame: In 2 years
1) proportion of eligible recruited patients 2)proportion of recruited patients who completed the study 3) proportion of protocol violation
Variation in left ventricular ejection fraction
Time frame: 6 hours post infusion
3 secondary outcomes
Numbers of donated hearts
Time frame: On organ donation surgery
Incidence of de novo atrial fibrillation
Time frame: From beginning of infusion until beginning of retrieval surgery
Time from recruitment to the administration of the study drug
Time frame: From randomization to 12 hours post randomization
Results and safety
The study was stopped early (reason given: Recruitment was too slow and we cannot anticipate to recruit the target sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 31179831Frenette AJ, Williamson D, Williams V, Lagace AM, Charbonney E, Serri K. A Pilot Randomized Controlled Trial Comparing Levothyroxine to Placebo in Neurologically Deceased Donors. Prog Transplant. 2019 Sep;29(3):261-268. doi: 10.1177/1526924819855083. Epub 2019 Jun 9.
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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.
Anne Julie Frenette, M.Sc principal investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
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 in people with Brain Dead Organ Donors, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 6 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: stopped early, as of the sponsor's last update on 17 Jul 2018. 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 Canada. 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 was stopped early (reason given: Recruitment was too slow and we cannot anticipate to recruit the target sample size). Results are not available in the source record.
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?
Study feasibility (time frame: In 2 years). 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 NCT02211053, 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 17 Jul 2018.