Epidemiology, Acute Management, and Outcomes of Patients With Sepsis Presenting to a Referral Hospital in Western Kenya

Summary

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.

Conditions

• Sepsis
• Severe Sepsis
• Septic Shock

Interventions

OTHER

WHO algorithm of fluid boluses guided by physical examination

OTHER

Frequent patient monitoring

Vital signs and physical exam every 30-60 minutes

OTHER

Early administration of empiric antibiotics

Clinician will be prompted to administer antibiotics within 60 minutes

OTHER

Oxygen delivery

OTHER

Correction of hypoglycemia

If blood glucose is less than 3.0 mmol/L, IV dextrose will be administered

OTHER

Correction of severe anemia

If hemoglobin is less than 7 mg/dL, clinician will be prompted to offer blood transfusion

Sponsors & Collaborators

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• Moi University

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Nathan M Thielman, MD, MPH · Duke University

• Charles Kwobah, MBChB, MMed · Moi University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2016-08-31

Completion

2016-09-30

Countries

• Kenya

Study Locations