Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Vanderbilt University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- In-hospital all cause mortality
Study Overview
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 regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.
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 early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Need for urgent surgery
Arms & Interventions
Simplified Severe Sepsis Protocol
This protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.
Intervention: Simplified Severe Sepsis Protocol (Other)
Usual care
Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders.
Intervention: Simplified Severe Sepsis Protocol (Other)
Outcomes
Primary Outcomes
In-hospital all cause mortality
Time Frame: During hospitalization, expected average 14 days
Secondary Outcomes
- 28-day all cause mortality adjusted for baseline illness severity(28-day)
- Treatment cost per patient(During hospitalization, expected average 14 days)
- 28-day all-cause mortality(28-day)
- In-hospital all cause mortality adjusted for illness severity(During hospitalization, expected average 14 days)
- Cumulative adverse events(During hospitalization, expected average 14 days)
- Antibiotic changed due to culture results(During hospitalization, expected average 14 days)