Abstract

The Human Subjects Core (HSC) will serve all three subprojects and its mandate is to oversee patient? protection. The HSC will assure this protection through development of standard operating procedures (SOPs);? obtaining IRB approval and verifying Office of Human Research Protection (CHRP) assurances to conduct this? research study; providing expert training that requires certification to ensure that each individual is qualified to? execute protocol procedures; and ongoing monitoring of compliance with regard to all procedures. HSC will? support each subproject is as follows:? Subproject #1 (Clinical efficacy). Training and certifying of clinical personnel at each site; Training of study? personnel for screening, enrolment, randomization and data collection; training monitoring for data safety.? Subproject #2 (Mechanisms of action). Training of study personnel for sample collection, processing and? shipping; Monitoring for data safety, sample coding and de-identification.? Subproject #3 (Costs and cost-effectiveness). Training of study personnel for data collection (resource? units, care logs etc.); Monitoring for data safety (cost and resource use data).? All subprojects. Human research protection training; IRB approvals and OHRP assurances; Development of? SOPs and Manual of operations and procedures; Auditing and monitoring of sites; Site education.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Specialized Center (P50)
Project #
5P50GM076659-02
Application #
7500302
Study Section
Special Emphasis Panel (ZGM1)
Project Start
Project End
Budget Start
2007-09-01
Budget End
2008-08-31
Support Year
2
Fiscal Year
2007
Total Cost
$193,281
Indirect Cost

  Institution

Name
University of Pittsburgh
Department
Type
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213

  Publications

Higgins, Sarah J; De Ceunynck, Karen; Kellum, John A et al. (2018) Tie2 protects the vasculature against thrombus formation in systemic inflammation. J Clin Invest 128:1471-1484
Massey, Michael J; Hou, Peter C; Filbin, Michael et al. (2018) Microcirculatory perfusion disturbances in septic shock: results from the ProCESS trial. Crit Care 22:308
Fabian-Jessing, Bjorn K; Massey, Michael J; Filbin, Michael R et al. (2018) In vivo quantification of rolling and adhered leukocytes in human sepsis. Crit Care 22:240
PRISM Investigators; Rowan, Kathryn M; Angus, Derek C et al. (2017) Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med 376:2223-2234
Kellum, John A; Pike, Francis; Yealy, Donald M et al. (2017) Relationship Between Alternative Resuscitation Strategies, Host Response and Injury Biomarkers, and Outcome in Septic Shock: Analysis of the Protocol-Based Care for Early Septic Shock Study. Crit Care Med 45:438-445
Hou, Peter C; Filbin, Michael R; Wang, Henry et al. (2017) Endothelial Permeability and Hemostasis in Septic Shock: Results From the ProCESS Trial. Chest 152:22-31
Kellum, John A; Chawla, Lakhmir S; Keener, Christopher et al. (2016) The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock. Am J Respir Crit Care Med 193:281-7
Angus, Derek C; Seymour, Christopher W; Coopersmith, Craig M et al. (2016) A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria. Crit Care Med 44:e113-21
Puskarich, Michael A; Shapiro, Nathan I; Massey, Michael J et al. (2016) Lactate Clearance in Septic Shock Is Not a Surrogate for Improved Microcirculatory Flow. Acad Emerg Med 23:690-3
Armen, Scott B; Freer, Carol V; Showalter, John W et al. (2016) Improving Outcomes in Patients With Sepsis. Am J Med Qual 31:56-63

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