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OpenTrials
Completed

NCT Number: NCT04054999

Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

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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Key information

Conditions

Vasoplegic Syndrome Cardiovascular Diseases Liver Transplant; Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases Vasoplegia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Hydroxocobalamin

Drug

Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes

Methylene Blue

Drug

Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Primary outcomes

  1. Systemic Vascular Resistance (SVR)

    Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

    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.

  2. Systolic Blood Pressure

    Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

    Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

  3. Diastolic Blood Pressure

    Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

    Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

  4. Vasopressin

    Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

    Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Secondary outcomes

  1. Post-operative Intensive Care Unit (ICU) Length of Stay

    Time frame: Up to 30 days after surgery

    Total number of days subjects were admitted to the ICU

  2. Hospital Length of Stay

    Time frame: Up to 30 days after surgery

    Total number of days subjects were admitted to the hospital

  3. Post-operative Complications

    Time frame: Up to 30 days after surgery

    The number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 13, 2019
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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