Pulmonary/Critical Care/Sleep Medicine Research
Restful sleep is a critical part of healthy living so it is important to identify sleep problems. Our Pulmonary/Critical Care/Sleep teams provide clinical evaluation, treatments for sleep-related disorders, and research study participation opportunities.
Methylene Blue in Septic Shock
Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
A randomized, prospective, non-blinded study to investigate the improvement of mean arterial pressure (MAP) at 1 hour by comparing Methylene Blue (ProvayBlue®) to phenylephrine, as a third line vasopressor
PROTOCOL DESCRIPTION
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors 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.
Inclusion Criteria
- Must be at least 18 years of age
- Meets Sepsis-3 Criteria and in Septic Shock
- ICU Admission
Exclusion Criteria
- Children less than 18 years old
- Pregnant women or positive urinary pregnancy test in reproductive-aged women
- Evolving myocardial infarction or known cardiomyopathy with documented EF<35%
- Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
- Severe renal failure is a contraindication to use of ProvayBlue®.
Primary Investigator(s):
Frank H. Biscardi, M.D.
Contact Information:
Ruth Ndolo, R.N.
Clinical Research Nurse
Phone: 540-266-6557
Email: rmndolo@carilionclinic.org
Pulmonary Hypertension in COPD
Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PERFECT Study)
A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
PROTOCOL DESCRIPTION
This is a multicenter, randomized, double-blind, placebo-controlled, 34-week, cross-over study with a Treatment Period of approximately 26 weeks under the Original Design or, if applicable, a 21-week parallel study with a Treatment Period of approximately 14 weeks under the Contingent Design.
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age
- Diagnosis of PH-COPD (WHO Group 3)
- Able to perform a 6 Minute Walk Test
Exclusion Criteria:
- Pulmonary hypertension caused by anything other than COPD
- Received any FDA approved-medication for the treatment of PAH within 60 days of screening
- Diagnosis of alpha-1 antitrypsin deficiency
- Any prior intolerance to prostanoid therapy
- Clinically significant left-sided heart disease or other cardiac conditions
- Receiving >10L/min of oxygen supplementation by any mode of delivery while at rest
- Current use of inhaled tobacco products, electronic cigarettes, and/or inhaled marijuana
- BMI greater than 45 kg/m2
Primary Investigator(s):
Sameh Aziz, M.D.
Contact Information:
Jessica Mays, B.S.
Clinical Research Coordinator
540-985-8067
