Simplified Severe Sepsis Protocol-2 (SSSP-2) in Zambia

• In-hospital all cause mortality [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]
  

• 28-day all-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: No ]
  
• In-hospital all cause mortality adjusted for illness severity [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]
  Adjusted for SAPS3 score
  
  
• 28-day all cause mortality adjusted for baseline illness severity [ Time Frame: 28-day ] [ Designated as safety issue: No ]
  Adjusted for SAPS3 score
  
  
• Cumulative adverse events [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: Yes ]
  A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.
  
  
• Treatment cost per patient [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]
  A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.
  
  
• Antibiotic changed due to culture results [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]
  The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.
  
  

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. In sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Studies of fluid interventions in the region, however, have demonstrated conflicting results. Outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis.

The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis with hypotensionor septic shock, (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, and (4) To assess the performance of the Xpert TB/RIF rapid PCR system and urine lipoarabinomannan assay for diagnosing tuberculosis in HIV positive patients with severe sepsis.