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

  CRITICAL CARE TRIALS

Active protocols
Protocol Name: Clinical Factors Associated with the development of severe sepsis in patients being treated for acute myeloid leukemia (AML).
Sponsor: NIH
PI: Naeem Ali, MD
Coordinator: Yahaira Kane
Synopsis: Observational Study. Subject population consists of patients admitted for inpatient therapy of AML. The protocol will investigate the role of hyperglycemia in the morbidity and mortality associated with AML treatment, and whether TSP-1 is important in modulating the course of sepsis induced acute lung injury.  Study procedures include CRF completion three blood draws: one at baseline, another at the onset of fever and a third 48 hours post fever.

Protocol Name: Phase II Clinical Trial of Two Approaches to High Frequency Oscillatory Ventilation in Acute Respiratory Distress Syndrome (HFOV)
Sponsor: NIH/Johns Hopkins University
PI: James O’Brien, MD
Co-I’s: Naeem Ali, MD/Beth Besecker, MD/Eric Adkins, MD/ Matthew Exline, MD
Coordinator: Yahaira Kane
Synopsis: This is an exploratory clinical trial designed to characterized and compare clinical, physiologic, and biochemical responses of acute respiratory distress syndrome (ARDS) patients who receive two different approaches to the use of High Frequency Oscillatory Ventilation (HFOV). Enrolled subjects are randomized to one of 2 groups: 1) HFOV with higher airway pressures, and 2) HFOV with lower airway pressures.

Protocol Name: Clinical Determinants of Handgrip strength in critically ill adult’s pilot study
Sponsor: OSU Critical Care Center
PI: Naeem A. Ali, MD
Co-I’s: James O’Brien, MD; Leanne K. Strack, DO
Coordinator: Luke Davis                                                                                  
Synopsis: To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit. 

Protocol Name: Protocolized Care for Early Septic Shock (ProCESS).
Sponsor: NIH/University of Pittsburg
PI: Naeem Ali, MD
Coordinator: Luke Davis
Synopsis: The study objective is to improve the management of septic shock by exploring the clinical, biological, and economic aspects of alternative resuscitation strategies.  This will be done by comparing two alternative resuscitation strategies, Early Goal Directed Therapy (EGDT) or Protocolized Standard Care (PSC), to usual care in subjects with septic shock.

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: Luke Davis
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:  Calfactant therapy for Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children.
Sponsor: Pneuma Pharmaceuticals Inc.
PI: James O’Brien, MD
Co-I’s: Naeem Ali, MD/ Beth Besecker, MD/Eric Adkins, MD/ Matthew Exline, MD
Coordinator: Anita Kapil
Synopsis: This purpose of this study is to evaluate the tolerability of calfactant when given to children or adults with ALI/ARDS.  The other reasons are to see if treatment with calfactant can: 1) improve the amount of oxygen in the blood, 2) decrease the amount of time adults and children with ALI/ARDS need on a breathing machine and 3) Increase survival of adults and children with ALI/ARDS.  At Ohio State we will only be studying the use of calfactant in adults.

Protocols currently on-hold

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:  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.  This means that the computer program is a research tool that has not been cleared or approved for general patient use. The FDA has determined that eProtocol-insulin has no significant risks.

Upcoming Protocols

Protocol Name: Comparison of burn severity and patient outcomes to the subsets of mesenchymal stem cells identified in the blood of burn victims
Sponsor: OSU Critical Care Center
PI: Daniel Zelinski, MD
Co-I: Chandan Shen, Ph.D.
Coordinator: Yahaira Kane
Synopsis: This study is designed to identify and measure the number of mesenchymal stem cells that are released into the blood stream following a thermal burn.  Study procedures include CRF completion and 2 blood draws: the first will take place within the first 24 hours of the acquired burn and the second sample will be collected within 72 hours of the burn.