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This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanokit | Experimental | Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes |
|
| Methylene Blue | Active Comparator | Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxocobalamin | Drug | Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Vascular Resistance (SVR) | SVR refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
| Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
| Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
| Vasopressin | Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Intensive Care Unit (ICU) Length of Stay | Total number of days subjects were admitted to the ICU | Up to 30 days after surgery |
| Hospital Length of Stay | Total number of days subjects were admitted to the hospital |
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| Name | Affiliation | Role |
|---|---|---|
| Sher-Lu Pai, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyanokit | Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes |
| FG001 | Methylene Blue | Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes Methylene Blue: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyanokit | Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes |
| BG001 | Methylene Blue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systemic Vascular Resistance (SVR) | SVR refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | Data was not collected nor analyzed at all for one participant in the Methylene Blue arm. The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed. | Posted | Median | Full Range | dyne*sec/cm^5 | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
|
Adverse Events were collected from baseline until hospital discharge, approximately two months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyanokit | Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary event | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sher-Lu Pai, M.D. | Mayo Clinic | 904-956-3327 | Pai.SherLu@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2019 | May 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006879 | Hydroxocobalamin |
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 |
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Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue
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| Methylene Blue |
| Drug |
Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes |
|
| Up to 30 days after surgery |
| Post-operative Complications | The number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other. | Up to 30 days after surgery |
Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Methylene Blue: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Methylene Blue | Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes Methylene Blue: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes |
|
|
| Primary | Systolic Blood Pressure | Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed. | Posted | Median | Full Range | Millimeters of Mercury | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
|
|
|
| Primary | Diastolic Blood Pressure | Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed. | Posted | Median | Full Range | Millimeters of Mercury | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
|
|
|
| Primary | Vasopressin | Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment. | Posted | Median | Full Range | milli-units/kg/min | 15, 30, 60, 90 and 120 minutes after initiation of treatment |
|
|
|
| Secondary | Post-operative Intensive Care Unit (ICU) Length of Stay | Total number of days subjects were admitted to the ICU | Posted | Median | Full Range | days | Up to 30 days after surgery |
|
|
|
| Secondary | Hospital Length of Stay | Total number of days subjects were admitted to the hospital | Posted | Median | Full Range | days | Up to 30 days after surgery |
|
|
|
| Secondary | Post-operative Complications | The number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other. | Posted | Number | participants | Up to 30 days after surgery |
|
|
|
| 1 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Methylene Blue | Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes Methylene Blue: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes | 1 | 10 | 0 | 10 | 2 | 10 |
| Surgical and medical procedures - Other. | Surgical and medical procedures | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| 30 minutes |
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| 60 minutes |
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| 90 minutes |
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| 120 minutes |
|
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| 30 minutes |
|
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| 60 minutes |
|
|
| 90 minutes |
|
|
| 120 minutes |
|
|
| 60 minutes |
|
| 90 minutes |
|
| 120 minutes |
|
| AKI |
|
| MI |
|
| Stroke |
|
| Surgical and medical procedures - Other. |
|