Protocolized Care for Early Septic Shock (ProCESS)

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.

Patients will be randomized to one of three groups:

1: Experimental

Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion.

Procedure: Early Goal Directed Therapy (EGDT)
Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements.

2: Experimental

Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.

Procedure: Protocolized Standard Care (PSC)
Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status.

3: Control Group

Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens. Procedure: Usual Care (UC)

Further Information:
ProCESS Web Site
NIH CLinical Trials Web Site for the ProCESS Study

Inclusion Exclusion Criteria

Inclusion criteria:

• 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 mmHg despite an IV fluid challenge of at least 20ml/kg over a 30 minute period) or evidence of hypoperfusion (a blood lactate concentration >/= 4mmol/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