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

Duke University

Status

Completed

Conditions

Severe Sepsis

Septic Shock

Sepsis

Treatments

Other: Oxygen delivery

Other: Early administration of empiric antibiotics

Other: WHO algorithm of fluid boluses guided by physical examination

Other: Frequent patient monitoring

Other: Correction of hypoglycemia

Other: Correction of severe anemia

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02346331

Pro00056846

R25TW009337 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

198 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Presenting to MTRH Casualty Department for acute medical care
Suspected infection, in the judgment of the managing clinician
At least 2 of the following: axillary temperature >37.5°C or <35.5°C or core temperature >38.0°C or <36.0°C; heart rate >90 beats per minute; respiratory rate >20 breaths per minute; or systolic blood pressure <100 mmHg

Exclusion criteria

Lack of basic language skills in either English or Kiswahili
Pregnancy
Congestive heart failure or valvular heart disease (as a known prior diagnosis or in the judgment of the managing clinician)
Need for immediate surgery (within 6 hours) in the judgment of the managing clinician
Inability to consent to study participation and lack of accompaniment by a family member or other surrogate who can provide consent

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

198 participants in 2 patient groups

WHO intervention

Experimental group

Description:

This arm will be treated with the 2011 WHO sepsis recommendations for the first 6 hours of their hospitalization. The WHO recommendations involve fluid boluses guided by vital signs and physical exam, frequent patient monitoring, rapid and early administration of empiric antibiotics, oxygen delivery, correction of hypoglycemia, and correction of severe anemia.

Treatment: