Septic Shock, Severe Sepsis
Conditions
Keywords
sepsis, shock, emergency department, resuscitation
Brief summary
The purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. We will randomly assign patients to one of two treatment methods. One of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. The second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. This study will attempt to determine an easier method of guiding treatment.
Interventions
PROCEDUREModified EGDT
Early goal directed therapy with lactate clearance
PROCEDUREStandard EGDT
Early goal directed therapy
Sponsors
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suspected infection 2. Any two of four criteria of systemic inflammatory response 3. SBP \< 90 mm Hg after 20cc/kg crystalloid (septic shock) or either a whole blood lactate \> 4 mmol/L (severe sepsis).
Exclusion criteria
1. Age \< 18 years 2. Pregnancy 3. Established Do Not Resuscitate orders prior to enrollment 4. Primary diagnosis other than sepsis 5. Requirement for immediate surgery in \< 6 hours from admission 6. Any absolute contraindication to central venous catheterization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | In-hospital |
Countries
United States
Outcome results
None listed