N/A
N=1,351
Protocolized Care for Early Septic Shock
Sepsis · Severe Sepsis · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT00510835 ↗Enrolled (actual)
1,351
Serious AEs
6.1%
Results posted
Jan 2017
Primary outcome: Primary: Hospital Mortality — 92; 81; 86 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early Goal Directed Therapy (EGDT) (Procedure); Protocolized Standard Care (PSC) (Procedure); Usual Care (UC) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Mortality |
92; 81; 86 | — |
| SECONDARY Changes in Markers of Inflammation, Oxidative Stress, Cellular Hypoxia and Coagulation/Thrombosis. |
— | — |
| SECONDARY Resource Use and Costs of Alternative Resuscitation Strategies |
— | — |
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.
Eligibility Criteria
Inclusion criteria
- At least 18 years of age
- Suspected infection
- Two or more systemic inflammatory response syndrome (SIRS) criteria
- Temperature /= 38˚C
- Heart rate >/= 90 beats per minute
- Mechanical ventilation for acute respiratory process or respiratory rate >/= 20 breaths per minute or PaC02 /= 12,000/mm³ OR 10% bands
- Refractory hypotension (a systolic blood pressure /= 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
Data sourced from ClinicalTrials.gov (NCT00510835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.