Simplified Severe Sepsis Protocol in Zambia
Simplified Severe Sepsis Protocol in Zambia
This study is a randomized control trial assessing the impact of a simple evidence-based
 protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a
 scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood
 transfusion when necessary. It is hypothesized that the protocol will significantly decrease
 in-hospital mortality in patients with severe sepsis.
In recent years, evidence-based protocols of bundled therapies have improved survival of
 severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such
 as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although
 tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis
 of tuberculosis-associated severe sepsis remains elusive.

 The aims of this study are (1) To assess the impact on survival of a simple evidence-based
 protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified
 severe sepsis protocol (3) To develop a clinical diagnostic score for identifying
 tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the
 Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with
 severe sepsis.
Inclusion Criteria:

 -  Age 18 or older

 -  Suspected infection

 -  2 or more of SIRS criteria:

 -  Heart rate >90/min

 -  Respiratory rate >20/min

 -  Temperature >= 38° C or <= 36° C

 -  White blood count > 12,000 or < 4,000/µL

 -  1 or more of the following signs of end-organ dysfunction

 -  Systolic blood pressure < 90 mm Hg

 -  Mean arterial blood pressure (MAP) < 65 mm Hg

 -  Confusion/altered mentation

 -  Urine output < 0.5 mL/kg/hr

 -  Creatinine increase > 0.5 mg/dL

 -  Creatinine > 0.5 mg/dL above upper limit of normal

 -  Platelet < 100x109/L

 -  Respiratory rate > 40/min

 -  Jaundice

 Exclusion Criteria:

 -  GI bleed

 -  Need for urgent surgery