- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04089072
Methylene Blue as a Third-line Vasopressor in Septic Shock
Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Frank Biscardi, MD
- Phone Number: 540-981-7000
- Email: fhbiscardi@carilionclinic.org
Study Contact Backup
- Name: Ruth Ndolo, RN
- Phone Number: 540-266-6557
- Email: rmndolo@carilionclinic.org
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Clinic
-
Contact:
- Frank Biscardi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Meets Sepsis-3 Criteria (Suspected source of infection plus any 2 criteria of the qSOFA)
2 .Septic Shock (any patient requiring vasopressor therapy to maintain MAP >65 mmHg or any patient with serum lactate >2 mmol/dL even in the absence of hypovolemia ).
3) Greater than 18 years old
4 ) ICU Admission
Exclusion Criteria:
Inability to obtain informed consent from an appropriate surrogate decision maker.
Also:
- Children less than 18 years old
- Pregnant women or positive urinary pregnancy test in reproductive-aged women
- Prisoners
- Evolving myocardial infarction or known cardiomyopathy with documented EF<35%
- Known grade 3 diastolic dysfunction document by echocardiogram
- Known hypersensitivity to thiazine dyes
- Pulmonary hypertension that is currently requiring vasodilator therapy
- Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
- Known documented history of G6PD deficiency or favism
- Active prior to admission medication prescription for a SSRI or SNRI , systemic heparin anticoagulation or other medications listed above (under Study Agent). These medications will be listed in the printed enrollment form.
- Severe renal failure is a contraindication to use of ProvayBlue®.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control group
Patients in the control group will have phenylephrine infusion starting at 50 mcg/min and titrated to maintain a MAP >65 mmHg as a third line vasopressor.
Maximum dose of Phenylephrine is 300 mcg/min.
|
Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin) already , they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor. Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock. |
Experimental: Intervention group
Patients enrolled in the intervention group will receive 2 mg/kg IBW (Ideal Body Weight) bolus, given over 15 mins, of ProvayBlue® followed by a concomitant infusion at 2 mg/kg/hr (IBW) mixed in D5W, which will continue for 24 hours.
ProvayBlue® ( Methylene Blue) will be used as the third-line vasopressor.
|
Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin), they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor. Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean arterial pressure
Time Frame: One hour and 24 hours after dose
|
The primary objective is to determine if the administration of ProvayBlue® is non-inferior to the use of phenylephrine as a third-line vasopressor to keep a mean arterial pressure (MAP)>65 mmhg after one hour and at 24 hours after the initiation of the drugs.
|
One hour and 24 hours after dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of acute kidney injury requiring dialysis
Time Frame: through time of patient discharge, an average of 8 days after admission
|
The secondary objectives are to see if the total vasopressor dosing and renal replacement needs are different in those patients receiving ProvayBlue® rather than standard care with escalating number of vasopressors.
|
through time of patient discharge, an average of 8 days after admission
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Biscardi, Carilion Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Shock, Septic
- Shock
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Methylene Blue
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- IRB 19-549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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