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| Name | Class |
|---|---|
| We Are Sharing Hope SC | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Control | No Intervention | No levothyroxine or methylprednisolone administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine | Drug |
| ||
| Methylprednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline (t0) = beginning of active donor management to procurement (tOR) = time of organ procurement, up to 50 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of organs procured vs. consented, stratified by treatment group | 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 |
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Inclusion Criteria:
Cadaveric organ donors ≥ age 18 having valid consent (by advance directive or by familial consent) to donate organs.
Recipients of these cadaveric organs
Exclusion Criteria:
Cadavers failing to meet inclusion criteria
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35389961 | Derived | 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. |
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There is currently no plan in place to share IPD for this study
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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| Drug |
|
| 90 days post transplant |
| Recipient Mortality | Recipient death by 90 days post transplant | 90 days post traansplant |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |