Brain DeathNCT04528797
Thyroid and Adrenocortical Hormone Replacement in Organ Donors
A study testing Levothyroxine and Methylprednisolone in people with Brain Death, run by Medical University of South Carolina.
Trial summary
Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- What is being tested?
- Levothyroxine and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2010to 30 Sep 2013
- 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
- Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.
- Recipients of these cadaveric organs
Who cannot join
- Cadavers failing to meet inclusion criteria
About this study
Official title: Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement
Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function.
Trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. Further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids.
Read more
The specific aims of this study include:
- To quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls)
- To document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls)
- To quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).
- Conditions
- Brain Death
- Being tested
- Levothyroxine, Methylprednisolone
- 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
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement. Receives: Drug: Levothyroxine |
| Methylprednisolone | Experimental | Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later. Receives: Drug: Methylprednisolone |
| Combination | Experimental | Methylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement. Receives: Drug: Levothyroxine; Drug: Methylprednisolone |
| Control | No intervention | No levothyroxine or methylprednisolone administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.
The VIS score includes all commonly used vasopressor and inotrope agents, weighted by potency and summed
Measured: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
Secondary outcomes (3)
Proportion of organs procured vs. consented, stratified by treatment group
Measured: assessed at time of procurement, up to 50 hours following consent for donation
Recipient Morbidity
Selected graft recipient morbidity measures in all organs transplanted stratified by treatment group
Measured: 90 days post transplant
Recipient Mortality
Recipient death by 90 days post transplant
Measured: 90 days post traansplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start2 Sep 2010
- Primary completion9 Aug 2012
- Study completion30 Sep 2013
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 DeathStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- We Are Sharing Hope SC
- Responsible party
- Principal investigator, Adrian Van Bakel, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528797
- Sponsor's protocol ID
- HR 17718
- Status last verified
- Aug 2020
- First submitted
- 20 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan in place to share IPD for this study
Publications
Van Bakel AB, Hino SA, Welker D, Morella K, Gregoski MJ, Craig ML, Crumbley AJ, Sade RM. Hemodynamic Effects of High-dose Levothyroxine and Methylprednisolone in Brain-dead Potential Organ Donors. Transplantation. 2022 Aug 1;106(8):1677-1689. doi: 10.1097/TP.0000000000004072. Epub 2022 Jul 22.
PubMed 35389961
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadaveric Organ Donor Management: Thyroid and Adrenocortical Hormone Replacement
- ClinicalTrials.gov ID
- NCT04528797
- Acronym / sponsor ID
- HR 17718
- Conditions
- Brain Death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- We Are Sharing Hope SC
- Study start
- 2 Sep 2010 (actual)
- Primary completion
- 9 Aug 2012 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 27 Aug 2020 (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.
Brain death inevitably leads to hemodynamic instability and prolonged hypotension that compromises viability of potentially transplantable organs. In addition to depletion of peripheral norepinephrine stores, concomitant depletion of thyroid hormone and cortisol levels are believed to contribute to this instability. Catecholamine vasopressors are widely used to support hemodynamics in potential organ donors, however their use has also been shown to compromise allograft function.
Trials studying the effects of thyroid hormone and corticosteroid treatment on brain dead organ donors have had mixed results with respect to improving donor hemodynamics. Further, few studies have attempted to discriminate the relative contribution of thyroid hormone vs. corticosteroids.
The specific aims of this study include:
- To quantify hemodynamic changes during the management of cadaveric organ donors routinely receiving thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those who do not receive any hormonal therapy (controls)
- To document number and types of organs procured in donors treated with thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to those not treated with hormonal therapy (controls)
- To quantify graft and patient outcomes in recipients of organs exposed to thyroid hormone therapy alone vs. corticosteroid therapy alone vs. the combination, compared to recipients of organs not exposed to hormonal therapy (controls).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: LevothyroxineLevothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement. |
| Methylprednisolone | Experimental | Drug: MethylprednisoloneMethylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later. |
| Combination | Experimental | Drug: Levothyroxine, Drug: MethylprednisoloneMethylprednsiolone 30 mg/kg (up to 2 g) IV initiated at the beginning of active donor management followed by repeat dosing of 15 mg/kg (up to 1 g) 12 hours later plus levothyroxine 20 mcg IV bolus initiated at the beginning of active donor management followed by continuous infusion of 50 to 200 mcg/hr titrated to minimize vasopressor requirements until organ procurement. |
| Control | No intervention | –No levothyroxine or methylprednisolone administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.
- Recipients of these cadaveric organs
Key exclusion criteria (1 listed)
- Cadavers failing to meet inclusion criteria
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 |
|---|---|---|
| Levothyroxine | Drug | Combination, Levothyroxine |
| Methylprednisolone | Drug | Combination, Methylprednisolone |
Primary outcome
Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement.
Time frame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours
The VIS score includes all commonly used vasopressor and inotrope agents, weighted by potency and summed
3 secondary outcomes
Proportion of organs procured vs. consented, stratified by treatment group
Time frame: assessed at time of procurement, up to 50 hours following consent for donation
Recipient Morbidity
Time frame: 90 days post transplant
Recipient Mortality
Time frame: 90 days post traansplant
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 27 Aug 2020.
- Derived from this study: PubMed 35389961Van Bakel AB, Hino SA, Welker D, Morella K, Gregoski MJ, Craig ML, Crumbley AJ, Sade RM. Hemodynamic Effects of High-dose Levothyroxine and Methylprednisolone in Brain-dead Potential Organ Donors. Transplantation. 2022 Aug 1;106(8):1677-1689. doi: 10.1097/TP.0000000000004072. Epub 2022 Jul 22.
- Individual participant dataSharing planned: No. There is currently no plan in place to share IPD for this study
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine and Methylprednisolone in people with Brain Death, run by Medical University of South Carolina.
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: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Vasoactive Inotrope Score (VIS) score from beginning of active donor management until procurement. (time frame: From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours). 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 NCT04528797, 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 Aug 2020.