Septic Shock
Conditions
Keywords
Methylene Blue, Vasopressors, Septic Shock, Provay Blue®
Brief summary
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).
Interventions
DRUGMethylene Blue
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.
DRUGPhenylephrine
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.
Sponsors
Provepharm Life Solutions
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Children less than 18 years old 2. Pregnant women or positive urinary pregnancy test in reproductive-aged women 3. Prisoners 4. Evolving myocardial infarction or known cardiomyopathy with documented EF\<35% 5. Known grade 3 diastolic dysfunction document by echocardiogram 6. Known hypersensitivity to thiazine dyes 7. Pulmonary hypertension that is currently requiring vasodilator therapy 8. Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic 9. Known documented history of G6PD deficiency or favism 10. 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. 11. Severe renal failure is a contraindication to use of ProvayBlue®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean arterial pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney injury requiring dialysis | 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. |
Countries
United States
Contacts
Primary ContactFrank Biscardi, MD
Backup ContactRuth Ndolo, RN
Outcome results
None listed