Protocolized Care for Early Septic Shock

Not Recruiting

Trial ID: NCT00510835


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.

Official Title

Protocolized Care for Early Septic Shock

Stanford Investigator(s)

Ronald Pearl
Ronald Pearl

Dr. Richard K. and Erika N. Richards Professor

Matthew Strehlow
Matthew Strehlow

Professor of Emergency Medicine (Adult Clinical/Academic)


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 < 32 mmHg

      - WBC >/= 12,000/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


procedure: Early Goal Directed Therapy (EGDT)

procedure: Protocolized Standard Care (PSC)

procedure: Usual Care (UC)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Valerie Ojha