NCT01449916

Simplified Severe Sepsis Protocol in Zambia

Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sepsis
• Severe Sepsis

Interventions

Type	Name	Description
OTHER	Simplified Severe Sepsis Protocol	Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-10-10
• Last updated: 2021-09-30

Locations

1 site across 1 country: Zambia