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

NCT ID: NCT02346331

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WHO intervention

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.

Group Type: EXPERIMENTAL

WHO algorithm of fluid boluses guided by physical examination

Intervention Type: OTHER

Frequent patient monitoring

Intervention Type: OTHER

Vital signs and physical exam every 30-60 minutes

Early administration of empiric antibiotics

Intervention Type: OTHER

Clinician will be prompted to administer antibiotics within 60 minutes

Oxygen delivery

Intervention Type: OTHER

Correction of hypoglycemia

Intervention Type: OTHER

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

Correction of severe anemia

Intervention Type: OTHER

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

Standard care

This arm will be managed per standard care by the hospital clinicians.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

WHO algorithm of fluid boluses guided by physical examination

Intervention Type: OTHER

Frequent patient monitoring

Vital signs and physical exam every 30-60 minutes

Intervention Type: OTHER

Early administration of empiric antibiotics

Clinician will be prompted to administer antibiotics within 60 minutes

Intervention Type: OTHER

Oxygen delivery

Intervention Type: OTHER

Correction of hypoglycemia

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

Intervention Type: OTHER

Correction of severe anemia

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Moi University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan M Thielman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Charles Kwobah, MBChB, MMed

Role: PRINCIPAL_INVESTIGATOR

Moi University

Locations

Moi Teaching and Referral Hospital

Eldoret, , Kenya

Countries

Kenya

Other Identifiers

R25TW009337

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00056846

Identifier Type: -

Identifier Source: org_study_id