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Methylene Blue for Septic Shock
Phase 2
Recruiting
Led By Frank Biscardi
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than 18 years old
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)
Must not have
Severe renal failure is a contraindication to use of ProvayBlue®.
Inability to obtain informed consent from an appropriate surrogate decision maker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour and 24 hours after dose
Awards & highlights
Summary
This trial compares two treatments for low blood pressure during surgery.
Who is the study for?
This trial is for adults over 18 with septic shock in the ICU, needing vasopressors to maintain blood pressure or having high lactate levels. They must meet Sepsis-3 Criteria but can't join if they have other forms of shock, severe heart issues, are on certain medications like SSRIs/SNRIs or systemic heparin, are pregnant, prisoners, have severe kidney failure, a recent heart attack or known allergies to thiazine dyes.
What is being tested?
The study tests Methylene Blue (ProvayBlue®) as an alternative third-line treatment against standard care involving multiple sympathomimetic vasopressors in patients with septic shock. It's a randomized and prospective study where participants are chosen by chance to receive either the test drug or standard treatment.
What are the potential side effects?
Methylene Blue may cause side effects such as changes in blood pressure and heart rate, skin discoloration (blue), nausea, vomiting, abdominal pain; Phenylephrine can increase blood pressure too much and also cause irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have septic shock and need medication to maintain my blood pressure or have high lactate levels.
Select...
I have been admitted to the ICU.
Select...
I meet the criteria for sepsis, including a suspected infection and two symptoms of qSOFA.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe kidney failure.
Select...
I cannot get consent from a decision maker on my behalf.
Select...
I have a history of G6PD deficiency or favism.
Select...
My heart's pumping ability is significantly reduced.
Select...
I am not pregnant or have not tested positive on a pregnancy test.
Select...
I have a severe heart condition diagnosed by an ultrasound of the heart.
Select...
I am on medication for high blood pressure in my lungs.
Select...
I am under 18 years old.
Select...
I am currently experiencing or suspected to have a type of shock.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one hour and 24 hours after dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour and 24 hours after dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systemic arterial pressure
Secondary study objectives
Incidence of acute kidney injury requiring dialysis
Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
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.
Group II: Control groupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylene blue
FDA approved
Phenylephrine
FDA approved
Find a Location
Who is running the clinical trial?
Carilion ClinicLead Sponsor
76 Previous Clinical Trials
14,641 Total Patients Enrolled
Provepharm Life SolutionsUNKNOWN
Frank BiscardiPrincipal InvestigatorCarilion Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe kidney failure.You have a known allergy to thiazine dyes.I cannot get consent from a decision maker on my behalf.I am older than 18 years.I have a history of G6PD deficiency or favism.I have septic shock and need medication to maintain my blood pressure or have high lactate levels.I have been admitted to the ICU.My heart's pumping ability is significantly reduced.I am not pregnant or have not tested positive on a pregnancy test.I have a severe heart condition diagnosed by an ultrasound of the heart.I am currently taking an SSRI, SNRI, heparin, or a medication listed in the enrollment form.I am on medication for high blood pressure in my lungs.I am under 18 years old.I am currently experiencing or suspected to have a type of shock.I meet the criteria for sepsis, including a suspected infection and two symptoms of qSOFA.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Intervention group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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