Ohio State Navbar

Research

Critical Care Trials


The ICU studies we are currently recruiting for are as follows:

Active protocols

Protocol Name: Statin Trial for Influenza Patients
Sponsor: Vanderbilt University Medical Center
PI: Matthew Exline, MD
Co-I's: Naeem Ali, MD/Beth Besecker, MD/Eric Adkins, MD/ James O’Brien, MD
Coordinator: Yahaira Kane
Synopsis: The purpose of this study is to assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require ICU admission due to respiratory distress. This is a Randomized, Placebo controlled Trial of the effectiveness of Statins for Preventing Mortality following ICU Admission for Influenza Complications.


Protocol Name: The Ohio State Sepsis Registry and Blood Bank
Sponsor: OSU Critical Care Center
PI: James O’Brien, MD
Co-I's: Naeem Ali, MD/Beth Besecker, MD/Eric Adkins, MD/ Matthew Exline, MD
Coordinator: Yahaira Kane
Synopsis: Data collection of all septic patients in the OSUMC MICU consists of a one time blood draw and follow-up calls. This data collection is not a primary research vehicle. It is primarily intended to allow for determination of disparities and inadequacies of care for subsequent intervention.


Protocol Name: Randomized Trial Comparing Early Versus Late Bronchoscopy in Hematopoietic Stem Cell Transplant Patients with Pulmonary Infiltrates
Sponsor: NIH/Wake Forest University Baptist Medical Center
PI: Karen Wood, MD
Co-I's: Shaheen Islam, MD/ Jennifer McCallister MD/Nitin Bhatt, MD/ Steven Devine, MD
Coordinator: Yahaira Kane
Synopsis: The purpose of this study is to determine the appropriate timing and usefulness of Fiberoptic Bronchoscopy (FOB) in hematopoietic stem cell transplant (HSCT) patients admitted to the Bone Marrow Transplant (BMT) Units with pulmonary infiltrates identified on chest x-ray or pulmonary CT scans, or with clinical suspicion of pulmonary origin of infection. Primary outcome measured will be differences in percentage of patients who had a change in therapy as a result of a bronchoscopy. Secondary outcomes include differences in in-hospital and 3 month mortality between the two groups, as well as differences in-hospital a 3 month mortality between groups in which a diagnosis was established versus those in which no diagnosis was established.


Protocol Name: Blood Glucose Control in Adult and Pediatric Intensive Care Unit Patients Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-insulin in Naïve ICUs (E-protocol)
Sponsor: OSU Critical Care Center
PI: Naeem Ali, MD
Coordinator: Anita Kapil
Synopsis: This is a research study to evaluate a computer program, called eProtocol-insulin that may help doctors and nurses take care of Intensive Care Unit (ICU) patients with high blood sugars. The Federal Food and Drug Administration (FDA) considers this computer program an investigational medical device. The purpose of this study is to: 1) find out how often the treating team agrees with the dose of insulin the computer recommends, 2) find out how well blood sugars are controlled with the computer program, 3) find out if and how often the dose of insulin the computer recommends leads to very low blood sugars, and 4) find out if nursing staff think that using the computer makes it easier to keep blood sugar in the normal range.


Protocol Name: Immune suppression and Ventilator Associated Pneumonia (iVAP)
Sponsor: OSU Critical Care Center
PI: Matthew Exline, MD
Co-I's: Naeem Ali, MD/Beth Besecker, MD/Eric Adkins, MD/ James O’Brien, MD
Coordinator: Yahaira Kane
Synopsis: The objective of this study will be to determine if we can detect which patients are at risk for developing secondary infections based on the level of monocyte activity as measured by cytokine production or concentration of inflammasome constituents as measured by mRNA and protein. The aim is to determine if immune suppression during recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.


Protocol Name: A prospective pilot study to evaluate the effect of mechanical ventilation on the inferior vena cava collapsibility index (IVCCI)
Sponsor: OSU Critical Care Center
PI: Eric Adkins, MD
Co-I's: Naeem Ali, MD
Coordinator: Yahaira Kane
Synopsis: The objective of this study is to identify non-invasive methods to decide how much resuscitation a patient might need. Current medical knowledge does not know if there is a difference between resuscitation needs of a patient on a ventilator and a patient who is not on a ventilator. The study involves the use of an ultrasound machine that will be used to look at the largest vein in the patient’s body called the inferior vena cava.


Protocol Name: The expression and significance of miRNA profile and markers of inflammation in patients with pulmonary arterial hypertension
Sponsor: Pulmonary Division
PI: Namita Sood, MD
Co-I's: Patrick Nana-Sinkam, MD
Coordinator: Anita Kapil
Synopsis: This study is being done to see if blood samples can be tested to determine who might develop PAH, how well drugs will work to treat PAH and to learn more about the development of PAH.


Protocol Name: LCRT:  Validation of a Multi-gene Test for Lung Cancer Risk
Sponsor: National Cancer Institute
PI: Patrick Nana-Sinkam, MD
Co-I's: Shaheen Islam, MD, Nitin Bhatt, MD,Karen Wood, MD, Michael Ezzie, MD
Coordinator: Anita Kapil
Synopsis:

A prospective, multi-center, blinded, nested case control study sponsored by the National Cancer Institute to demonstrate that the LCRT can be used as a risk prediction test for determining individuals at higher odds for developing lung cancer in the future based on a normal bronchial epithelial cell sample from a non-cancer bronchial site.
 

785 patients will be enrolled at 16 study sites in the United States. Patients will be undergoing a clinical diagnostic bronchoscopy, ages 50 to 90, at least a 20-pack year smoking history but without lung cancer.