Protocolized Care for Early Septic Shock (NCT00510835) | Clinical Trial Compass
CompletedNot Applicable
Protocolized Care for Early Septic Shock
United States1,351 participantsStarted 2008-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* At least 18 years of age
* Suspected infection
* Two or more systemic inflammatory response syndrome (SIRS) criteria
* Temperature \</= 36Ëš C or \>/= 38ËšC
* 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)
Exclusion criteria:
* 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
What they're measuring
1
Hospital Mortality
Timeframe: prior to discharge or 60 days, whichever comes first