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Methylene Blue for Septic Shock

Phase 2

Waitlist Available

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

No Placebo-Only Group

All Individual Drugs Already Approved

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 below

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I am older than 18 years.

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I have septic shock and need medication to maintain my blood pressure or have high lactate levels.

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I have been admitted to the ICU.

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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:

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I do not have severe kidney failure.

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I cannot get consent from a decision maker on my behalf.

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I have a history of G6PD deficiency or favism.

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My heart's pumping ability is significantly reduced.

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I am not pregnant or have not tested positive on a pregnancy test.

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I have a severe heart condition diagnosed by an ultrasound of the heart.

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I am on medication for high blood pressure in my lungs.

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I am under 18 years old.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour and 24 hours after dose for reporting.

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

Awards & Highlights

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.

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

0 / 13Eligibility criteria met