Status:
TERMINATED
Simplified Severe Sepsis Protocol in Zambia
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 reg...
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 ea...
Eligibility Criteria
Inclusion
- Age 18 or older
- Suspected infection
- 2 or more of SIRS criteria:
- Heart rate \>90/min
- Respiratory rate \>20/min
- Temperature \>= 38° C or \<= 36° C
- White blood count \> 12,000 or \< 4,000/µL
- 1 or more of the following signs of end-organ dysfunction
- Systolic blood pressure \< 90 mm Hg
- Mean arterial blood pressure (MAP) \< 65 mm Hg
- Confusion/altered mentation
- Urine output \< 0.5 mL/kg/hr
- Creatinine increase \> 0.5 mg/dL
- Creatinine \> 0.5 mg/dL above upper limit of normal
- Platelet \< 100x109/L
- Respiratory rate \> 40/min
- Jaundice
Exclusion
- GI bleed
- Need for urgent surgery
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01449916
Start Date
February 1 2012
End Date
November 1 2012
Last Update
September 30 2021
Active Locations (1)
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1
University Teaching Hospital
Lusaka, Zambia