A Phase 4 interventional study of Hydroxocobalamin and Methylene Blue in Vasoplegic Syndrome and Liver Transplant; Complications, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 19 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Drug: Hydroxocobalamin
Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Drug: Methylene Blue
Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment
Post-operative Intensive Care Unit (ICU) Length of Stay
Total number of days subjects were admitted to the ICU
Time frame: Up to 30 days after surgery
Hospital Length of Stay
Total number of days subjects were admitted to the hospital
Time frame: 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.
Time frame: Up to 30 days after surgery
| Milestone | Cyanokit | Methylene Blue |
|---|---|---|
| Started | 9 | 10 |
| Completed | 9 | 10 |
| Not completed | 0 | 0 |
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.
| dyne*sec/cm^5 | Cyanokit | Methylene Blue |
|---|---|---|
| 15 minutes | 480 (350 to 850) | 410 (380 to 570) |
| 30 minutes | 588 (330 to 770) | 420 (310 to 760) |
| 60 minutes | 650 (390 to 1170) | 480 (300 to 940) |
| 90 minutes | 571 (430 to 990) | 530 (330 to 610) |
| 120 minutes | 543 (440 to 1060) | 415 (340 to 670) |
Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
| Millimeters of Mercury | Cyanokit | Methylene Blue |
|---|---|---|
| 15 minutes | 109 (96 to 130) | 110 (63 to 120) |
| 30 minutes | 113 (97 to 147) | 101 (87 to 130) |
| 60 minutes | 120 (95 to 158) | 111 (92 to 145) |
| 90 minutes | 129 (104 to 152) | 111 (90 to 162) |
| 120 minutes | 116 (83 to 149) | 109 (101 to 161) |
Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
| Millimeters of Mercury | Cyanokit | Methylene Blue |
|---|---|---|
| 15 minutes | 58 (40 to 66) | 55 (39 to 62) |
| 30 minutes | 57 (43 to 72) | 55 (41 to 68) |
| 60 minutes | 61 (39 to 73) | 55 (47 to 78) |
| 90 minutes | 60 (42 to 72) | 57 (50 to 70) |
| 120 minutes | 59 (47 to 78) | 57 (49 to 98) |
Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
| milli-units/kg/min | Cyanokit | Methylene Blue |
|---|---|---|
| 15 minutes | 0.04 (0.00 to 0.17) | 0.04 (0.00 to 3.71) |
| 30 minutes | 0.04 (0.00 to 0.13) | 0.04 (0.00 to 3.37) |
| 60 minutes | 0.00 (0.00 to 0.13) | 0.02 (0.00 to 0.37) |
| 90 minutes | 0.00 (0.00 to 0.13) | 0.00 (0.00 to 0.37) |
| 120 minutes | 0.00 (0.00 to 0.11) | 0.00 (0.00 to 0.31) |
Total number of days subjects were admitted to the ICU
| days | Cyanokit | Methylene Blue |
|---|---|---|
| Post-operative Intensive Care Unit (ICU) Length of Stay | 1 (0 to 20) | 0 (0 to 4) |
Total number of days subjects were admitted to the hospital
| days | Cyanokit | Methylene Blue |
|---|---|---|
| Hospital Length of Stay | 7 (5 to 56) | 7 (0 to 12) |
The number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other.
| participants | Cyanokit | Methylene Blue |
|---|---|---|
| Death | 1 | 1 |
| Cardiopulmonary Event | 0 | 1 |
| AKI | 0 | 0 |
| MI | 0 | 0 |
| Stroke | 0 | 0 |
| Surgical and medical procedures - Other. | 1 | 1 |
Collected over Adverse Events were collected from baseline until hospital discharge, approximately two months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cyanokit | 1/9 (11.1%) | 0/9 (0%) | 1/9 (11.1%) |
| Methylene Blue | 1/10 (10%) | 0/10 (0%) | 2/10 (20%) |
| Event | Cyanokit | Methylene Blue |
|---|---|---|
| Surgical and medical procedures - Other.Surgical and medical procedures | 1/9 | 1/10 |
| Cardiopulmonary eventCardiac disorders | 0/9 | 1/10 |
| Age, Continuous(years) | Cyanokit | Methylene Blue | Total |
|---|---|---|---|
| Median | 65 (39 to 71) | 59 (44 to 69) | 65 (39 to 71) |
| Sex: Female, Male(Participants) | Cyanokit | Methylene Blue | Total |
|---|---|---|---|
| Female | 3 | 1 | 4 |
| Male | 6 | 9 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Cyanokit | Methylene Blue | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 9 | 8 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cyanokit | Methylene Blue | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 10 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cyanokit | Methylene Blue | Total |
|---|---|---|---|
| United States | 9 | 10 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2019 to primary completion in Feb 2023, 38 months.
Results were first posted in Jun 2024, 1 year 3 months after primary completion.
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Studies of the drug tested here: Hydroxocobalamin