A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
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.
Carilion Clinic
Roanoke, Virginia, United States
RECRUITINGChange 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.
Time frame: One hour and 24 hours after dose
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.
Time frame: through time of patient discharge, an average of 8 days after admission
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