Phase 4
N=19
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Vasoplegic Syndrome · Liver Transplant; Complications
Bottom Line
View on ClinicalTrials.gov: NCT04054999 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Systemic Vascular Resistance (SVR) — 480; 410; 588; 420 dyne*sec/cm^5
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydroxocobalamin (Drug); Methylene Blue (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Vascular Resistance (SVR) |
480; 410; 588; 420; 650; 480 | — |
| PRIMARY Systolic Blood Pressure |
109; 110; 113; 101; 120; 111 | — |
| PRIMARY Diastolic Blood Pressure |
58; 55; 57; 55; 61; 55 | — |
| PRIMARY Vasopressin |
0.04; 0.04; 0.04; 0.04; 0.00; 0.02 | — |
| SECONDARY Post-operative Intensive Care Unit (ICU) Length of Stay |
1; 0 | — |
| SECONDARY Hospital Length of Stay |
7; 7 | — |
| SECONDARY Post-operative Complications |
1; 1; 0; 1; 0; 0 | — |
Summary
This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
Eligibility Criteria
- Patients scheduled to undergo liver transplantation
- Patients able to read and understand consent document (if patient is unable to provide an informed consent, the Legally Authorized Representative will be ask to consent on behalf of the patient).
- SVR lower than 500 dynes-sec/cm-5 intraoperatively (this criterion must be met after consent intraoperatively)
Data sourced from ClinicalTrials.gov (NCT04054999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.