Last updated: July 22, 2022
Sponsor: Carilion Clinic
Overall Status: Active - Recruiting
Phase
2
Condition
Low Blood Pressure (Hypotension)
Sepsis And Septicemia
Treatment
N/AClinical Study ID
NCT04089072
IRB 19-549
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 anypatient with serum lactate >2 mmol/dL even in the absence of hypovolemia ). 3) Greater than 18 years old
4 ) ICU Admission
Exclusion
Exclusion Criteria: 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%
- 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 , systemicheparin anticoagulation or other medications listed above (under Study Agent). Thesemedications will be listed in the printed enrollment form.
- Severe renal failure is a contraindication to use of ProvayBlue®.
Study Design
Total Participants: 250
Study Start date:
December 01, 2019
Estimated Completion Date:
November 01, 2024
Study Description
Connect with a study center
Carilion Clinic
Roanoke, Virginia 24014
United StatesActive - Recruiting
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