Protocolized Care for Early Septic Shock

Completed · Not applicable

Conditions studied: Sepsis, Severe Sepsis, Septic Shock

In brief

The ProCESS study is large, 5-year, multicenter study of alternative resuscitation strategies for septic shock. The study hypothesizes that there are "golden hours" in the initial management of septic shock where prompt, rigorous, standardized care can improve clinical outcomes.

Key facts

Study ID

NCT00510835

Run by

University of Pittsburgh

People needed

1351

Starts

2008-03-01

Expected to finish

2013-12-01

Last updated by the study team

2017-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Suspected infection
• Two or more systemic inflammatory response syndrome (SIRS) criteria
• Temperature </= 36˚ C or >/= 38˚C
• Heart rate >/= 90 beats per minute
• Mechanical ventilation for acute respiratory process or respiratory rate >/= 20 breaths per minute or PaC02 < 32 mmHg
• WBC >/= 12,000/mm³ OR </= 4,000/mm³ OR > 10% bands
• Refractory hypotension (a systolic blood pressure < 90 mm Hg despite an IV fluid challenge of at least 1,000 mLs over a 30 minute period) or evidence of hypoperfusion (a blood lactate concentration >/= 4 mmol/L)

You may not qualify if…

• Known pregnancy
• Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, active gastrointestinal hemorrhage, seizure, drug overdose, burn or trauma
• Requirement for immediate surgery
• ANC < 500/mm³
• CD4 < 50/mm³
• Do-not-resuscitate status
• Advanced directives restricting implementation of the protocol
• Contraindication to central venous catheterization
• Contradiction to blood transfusion (e.g., Jehovah's Witness)
• Treating physician deems aggressive care unsuitable
• Participation in another interventional study
• Transferred from another in-hospital setting

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Maricopa Medical Center — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• LA County & USC Medical Center — Los Angeles, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Methodist Research Institute — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences Center/Shreveport — Shreveport, Louisiana, United States
• University of Maryland/Baltimore — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• State University of New York - Downstate Medical Center — Brooklyn, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• Summa Health System — Akron, Ohio, United States
• Penn State Hershey College of Medicine; Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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