Surgeons in the Section of Acute and Critical Care Surgery at Washington University School of Medicine have strong research interests in injury, sepsis (spread of bacteria from a focus of infection), hemostasis and multiple organ dysfunction.
Some of the research projects that our faculty members are actively collaborating on include:
- “Trauma Surgeon Workload Study”: The Trauma Surgeon Workload Study is a pilot project devised to quantify the amount of time spent in specific activities by trauma attending surgeons during trauma activations, and to determine the amount of time and the activities that are not reimbursed by currently available CPT codes. To quantify these reimbursement inequalities, the Trauma Center Association of America is conducting a prospective, observational study involving trauma surgeons. Clinical and nonclinical activities will be recorded and these data will be sent to an independent professional coder to compare the codes and charges he/she assigns with those assigned by the hospital coder. A research team member will shadow the trauma surgeon when he/she responds to a trauma activation to record information on time spent on activities surrounding the care of the patient. Led by Principal Investigator, Douglas J. E. Schuerer, MD.
- “A Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered”: In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using his/her usual surgical practice. These include, but are not limited to: suturing (stitches), ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often necessary for surgeons to use an additional treatment to stop the bleeding. This may include the use of a hemostatic product (used to stop bleeding). This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct to hemostasis. ClotFoam® is an investigational product—a gelatin-based hydrogel carrying a fibrin monomer—that has been designed for supportive treatment in general surgery for the improvement of hemostasis, where standard techniques are insufficient. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “A randomized trial of Supplemental Parenteral Nutrition in Under and Overweight Critically Ill Patients: The TOP UP Trial”: Critically ill patients can become malnourished quickly and this may lead to an increased rate of infections and death. Even though nutrition is an important part of standard patient care, studies show that patients in the intensive care units are not being fed well and on average they receive only 40-60% of the calories and protein that they should be receiving. Some data have also shown that giving more calories and protein to patients who are underweight (Body Mass Index (BMI) < 25) and those who are overweight (BMI > or = to 35) may improve their chances of survival. However, this practice needs to be tested in a proper trial, such as this one. The purpose of this study is to find out if giving more calories and protein to underweight and overweight critically ill patients (BMI <25 or > or =35) will improve their chances of survival. The aim of this pilot study is to evaluate whether providing energy and protein to the critically ill underweight and overweight patient through enteral nutrition supplemented with parenteral nutrition is feasible and improves clinical outcomes. The ultimate goal is to conduct a large multicenter, multinational randomized trial to answer this fundamental question. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “A Randomized, Prospective, Double-blind, Multi-center Study To Examine And Compare The Outcomes Associated With The Use Of Flex HD®, A Human Acellular Dermal Matrix, And Strattice™, A Porcine Acellular Dermal Matrix Allograft, When Used As A Reinforcing Material In The Repair Of Large Abdominal Wall Hernias By A Component Separation Technique”: Ventral hernia, a large weakness in the abdominal wall, is a complication that can arise after major abdominal surgery or abdominal trauma. Many surgical techniques have been developed to re-establish the integrity of the abdominal wall. These techniques include the placement of a supportive mesh for additional reinforcement of the abdominal wall weakness. Two types of mesh made from biological material are available to surgeons for abdominal wall reinforcement. Flex HD® is a Human Acellular Dermal Matrix (HADM) and Strattice™ is a Porcine Acellular Dermal Matrix Allograft (PADM). The current literature shows few, if any, prospective, randomized head-to-head comparisons of a human acellular dermal matrix (HADM) and a porcine acellular dermal matrix (PADM) when used as a reinforcing material in the repair of large abdominal hernias by component separation in a specific population. The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD® and Strattice when used as a reinforcing material in the repair of large complicated abdominal wall hernias. A secondary objective of the study is to evaluate integrity of repair/eventration/need for reoperation, based on the postoperative photographs obtained at 1-6 weeks, 6 months, and 12 months. An additional objective of this study is to assess patient satisfaction using the SF-36 questionnaire at 3 months, 6 months, and 12 months. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “A Non-Investigational Post-Market Trial Using EVARREST(TM) Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery”: In any abdominal, pelvic, retroperitoneal (behind your pelvis), or noncardiac thoracic surgery, bleeding usually occurs. Surgeons try to stop the bleeding by using his/her usual surgical practice. These include, but are not limited to: suturing (stitches), ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often necessary for surgeons to use an additional treatment to stop the bleeding. This may include the use of a hemostatic product (used to stop bleeding). This study is a post-marketing trial evaluating the clinical utility of EVARREST (TM) fibrin sealant patch (fibrin pad) as an adjunct to control soft tissue bleeding in intra-abdominal, pelvic, retroperitoneal, and noncardiac thoracic surgeries. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “Hemodynamic Instability Rules Based Advisor: The Impact to Care with a New Predictive Indicator”: A particular area of concern in modern Intensive Care Unit environments is hemodynamic instability (changes in blood pressure or cardiac function) in critically ill patients. The deterioration of blood pressure despite real-time and often, invasive, monitoring coupled with the use of therapies such as fluids and blood pressure medications remains an important challenge to clinical care teams. Clinical Decision Support (CDS) refers broadly to a variety of methods for providing the clinical care team with clinical knowledge and patient-related information, intelligently filtered and presented at the appropriate time to enhance patient safety and patient care. The purpose of this study is to evaluate the use of a clinical decision support tool to determine whether the use of this tool aides the care team in timely assessments to initiate prompt therapy or further diagnostic testing earlier, thus improving outcomes. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE IDE (MANAGE IDE)”: Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar), and glycemic variability (glucose variations) are independently associated with morbidity and mortality of critically ill patients. Implementation strategies of blood glucose control have mostly been accomplished with manually operated portable whole blood glucose meters, which suffer from a variety of error sources that can put intensively managed patients at risk for insulin over- and/or under-dosing. Furthermore, all manually operated whole blood glucose monitoring lacks trending, while immediate feedback and predictability of the effects of insulin infusions are highly needed when infusing insulin in critically ill patients. In addition, each blood glucose measurement requires a substantial volume of blood and is time-consuming. Automated, more frequent, plasma-based glucose monitoring has several potential advantages. First, it eliminates the variability associated with measuring glucose from pre-analytical, or potential “user” error. Second, it eliminates the potential for cross contamination between patients (as the disposable is dedicated to a patient over three days). Third, it could improve the safety and effectiveness of blood glucose control with insulin by improving all 3 domains of glycemic control: reducing hyperglycemia while at the same time preventing hypoglycemia and reducing glycemic variability. Fourth, it could reduce the volumes of blood consumed for blood glucose measurements, as well as the workloads associated with the high number of blood samples to be obtained and analyzed. The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects. The OptiScanner 5000 Glucose Monitoring System (OptiScanner) from OptiScan Biomedical Corporation is an automated, bedside, glucose monitoring system to quantitatively measure the concentration of blood glucose. When attached to a patient it automatically draws a small blood sample, processes it, returns the majority of the drawn blood back to the patient, and then provides a glucose value. Note that for the purposes of this clinical investigation, glucose values from the Optiscanner will not be visible to the user. Led by Principal Investigator, Grant V. Bochicchio, MD, MPH.
- “Tranexamic Acid Mechanisms and Pharmacokinetics In Traumatic Injury (TAMPITI Trial)”: This multicenter double- blind, randomized, placebo-controlled study will be performed under an IRB approval for exception from informed written consent (with community consultation) and with IND approval from the FDA. Participants will be randomized into 1 of 3 treatment arms (1:1:1): TXA 2 gram IV bolus, TXA 4 gram IV bolus, or placebo. A transfusion algorithm will be applied at both clinical centers to standardize transfusion practice in this trial. Both clinical sites will not use any hemostatic agents or coagulation factor concentrates within the transfusion algorithm used in the proposed trial. Led by Co-Principal Investigators, Grant V. Bochicchio, MD, MPH and Philip C. Spinella, MD. Dr. Spinella is associate professor for the Division of Critical Care Medicine in the Department of Pediatrics at Washington University School of Medicine.
- “Protocolized Early Echocardiographic Resuscitation”: Critically ill and injured patients often require a variety of interventions to maintain fluid balance and blood pressure. It can be difficult to determine which intervention to use if the cause of the imbalance or low blood pressure is unknown. This study will look at the possible benefit of using a tool to determine the causes of instability as well as a protocol aimed at optimizing cardiac performance to maintain tissue perfusion (oxygen supply), prevent organ failure, and improve outcomes (survival). This tool is a trans-esophageal echocardiographic probe, or TEE probe. It allows for the real time visualization of the heart and surrounding vessels. This probe is FDA approved for continuous use up to 72 hours. This is a smaller, more accessible version of the traditional probe used by cardiologists to look at the heart through the esophagus (mouth and throat). In this study, we will compare the protocolized approach to the standard approach used in the ICU for this type of patient. Standards of care, as well as the protocolized interventions include IV fluids given in larger, more rapid quantities (fluid boluses), the use of medications that work to correct the overdilation of blood vessels and thereby raise the blood pressure (vasopressors), and medications that increase the amount of blood ejected by the heart with each beat (inotropes). We will compare the interventions and outcomes of both groups. Led by Principal Investigator, Tiffany M. Osborn, MD, MPH, FACEP.
- “Early ICU Standardized Rehabilitation Therapy for the Critically Injured Burn Patient”: The purpose of this research study is to see if using early standardized rehabilitation therapy (a form of exercise) may help prevent or reduce the development of severe weakness in the arms and legs after being in the Burn ICU (intensive care unit). This weakness may be associated with the length of time a person requires the use of the breathing machine or how long they stay in the ICU or the hospital. Led by Principal Investigator, Bradley Freeman, MD.
- “A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically Ventilated Patients with Gram-Negative Pneumonia”: This is a prospective, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of 10 calendar day (20 doses) course of aerosolized BAY 41-6551 400 mg (amikacin as free base) every 12 hours versus placebo (normal saline) as adjunctive therapy in intubated and mechanically ventilated patients with Gram-negative pneumonia. All patients will receive parenteral antibiotics according to the 2005 American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines for the management of hospital-acquired pneumonia, ventilator-associated pneumonia, or healthcare-acquired pneumonia for 10 days. Patients who are extubated before completing the full course (10 calendar days if the first dose is administered in the AM or 11 calendar days if the first dose is administered in the PM [20 doses]) of aerosol therapy will be continued on aerosolized therapy with the handheld adapter. Led by Principal Investigator, John Mazuski, MD, PhD.
In addition to the research listed above the section staffs a basic science lab that is an integral part of the research that the Section of Acute and Critical Care Surgery produces.