Sepsis Clinical Trial
Official title:
Epidemiology, Acute Management, and Outcomes of Patients With Sepsis Presenting to a Referral Hospital in Western Kenya
Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia)
secondary to severe infection. In high-income countries (HICs), early resuscitation of septic
patients with protocol-driven therapy, including quantitative fluid administration guided by
invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and
mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income
countries; however, most hospitals in SSA lack the technology and resources necessary to
implement the resuscitation protocols used in HICs and therefore, mortality from sepsis
remains high. The World Health Organization (WHO) has recently disseminated an algorithm for
resuscitation of septic patients in low resource settings. This algorithm is based on expert
consensus only, and its efficacy has never been tested.
This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital
(MTRH) in Eldoret, Kenya.
The purpose of this study is to describe the epidemiology of patients presenting with severe
sepsis, to examine the microbiology causing severe sepsis, to describe current management and
outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation
algorithm at MTRH.
The study design is a prospective before and after clinical trial. In an initial
observational phase, adult patients presenting to the MTRH Casualty Department with sepsis
and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled
into a prospective observational cohort. Demographic data, medical characteristics, and
microbiological studies will be obtained, then the management and outcomes of these patients
will be observed. In a second phase, patients with sepsis will continue to be enrolled into a
prospective observational cohort, while patients with severe sepsis will be enrolled into an
intervention group. Patients in the intervention group will be managed according to the WHO
resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by
vital signs and physical exam findings, rapid and early administration of empiric
antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of
lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital,
and 30-day mortality.
n/a
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