Septic ShockPhase 2NCT04089072
Methylene Blue as a Third-line Vasopressor in Septic Shock
A Phase 2 study testing Methylene Blue and Phenylephrine in people with Septic Shock, run by Carilion Clinic at 1 site in United States.
Trial summary
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Methylene Blue and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 1 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- 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®.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Frank Biscardi
About this study
Official title: Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.
Read the detailed description
The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor. The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).
- Conditions
- Septic Shock
- Being tested
- Methylene Blue, Phenylephrine
- Keywords
- Methylene Blue, Vasopressors, Septic Shock, Provay Blue®
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called ProvayBlue®
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.
PhenylephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | 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. Receives: Drug: Phenylephrine |
| Intervention group | Experimental | 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. Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean arterial pressure
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.
Measured: One hour and 24 hours after dose
Secondary outcomes (1)
Incidence of acute kidney injury requiring dialysis
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.
Measured: through time of patient discharge, an average of 8 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Dec 2019
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Provepharm Life Solutions
- Responsible party
- Principal investigator, Frank H Biscardi, Carilion Clinic
- Investigators
- Frank Biscardi, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089072
- Sponsor's protocol ID
- IRB 19-549
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To publish aggregated data
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
- ClinicalTrials.gov ID
- NCT04089072
- Acronym / sponsor ID
- IRB 19-549
- Conditions
- Septic Shock
- Keywords
- Methylene Blue, Vasopressors, Septic Shock, Provay Blue®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Provepharm Life Solutions
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.
Detailed description
The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor. The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: PhenylephrinePatients 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. |
| Intervention group | Experimental | Drug: Methylene BluePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Inability to obtain informed consent from an appropriate surrogate decision maker.
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAlso: ProvayBlue®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. | Drug | Intervention group |
| PhenylephrinePrior 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. | Drug | Control group |
Primary outcome
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.
1 secondary outcome
Incidence of acute kidney injury requiring dialysis
Time frame: through time of patient discharge, an average of 8 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No. To publish aggregated data
Related trials for Septic Shock
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Biscardi principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylene Blue and Phenylephrine in people with Septic Shock, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Biscardi, MD (540-981-7000, fhbiscardi@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean arterial pressure (time frame: One hour and 24 hours after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.