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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one hour and 24 hours after dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Systemic arterial pressure

Secondary outcome measures

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

71 Previous Clinical Trials

12,456 Total Patients Enrolled

Provepharm Life SolutionsUNKNOWN

Frank BiscardiPrincipal InvestigatorCarilion Clinic

Media Library

Methylene Blue (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04089072 — Phase 2

Septic Shock Research Study Groups: Control group, Intervention group

Septic Shock Clinical Trial 2023: Methylene Blue Highlights & Side Effects. Trial Name: NCT04089072 — Phase 2

Methylene Blue (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04089072 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies can be remedied by administering phenylephrine?

"Phenylephrine is a viable remedy for nephritis, eye, and pupil-related issues."

Answered by AI

What is the uppermost limit of individuals participating in this clinical investigation?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical study, which was first posted December 1st 2019, is actively recruiting participants. A total of 250 patients are needed for the trial to be held at a single site."

Answered by AI

Has Phenylephrine been approved by the U.S. Food and Drug Administration?

"Due to the stage of this trial, there is some data confirming phenylephrine's safety but no evidence indicating efficacy. This results in it being assigned a 2 on our 1-3 scale."

Answered by AI

Has enrollment for this clinical research commenced?

"According to clinicaltrials.gov, this medical trial is presently searching for participants. The initial posting was on December 1st 2019 and the most recent update came July 22nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Methylene Blue as a Third-line Vasopressor in Septic Shock

Frank H Biscardi 2019. "Methylene Blue as a Third-line Vasopressor in Septic Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04089072.